目次Table of Contents

日本語 / Japanese ....................................................................................................... 03
English / 英語 .............................................................................................................. 31
別添 / Appendix........................................................................................................ 59

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition12Comprehensive and collaborative training
on medical innovations
adapted to challenges of clinical trials
in Asian and African countries[2nd edition]
日本語 / JAPANESE目次

目次 ......................................................................................................................................................................................

04

序文 ......................................................................................................................................................................................

06

謝辞 ......................................................................................................................................................................................

07

略語一覧 ..............................................................................................................................................................................

08

図表目次 ..............................................................................................................................................................................

09

1.

11

はじめに .......................................................................................................................................................................
1.1 研修概要 .....................................................................................................................................
1.2 研修の目的 .................................................................................................................................
1.3 研修生の背景 .............................................................................................................................

2.

NCGM 内のプログラム ..............................................................................................................................................
2.1
		
		
2.2
2.3
2.4
2.5
2.6
2.7
2.8

3.

11
11
11

臨床研究センター インターナショナルトライアル部（DIT） ...........................................
2.1.1 DIT の概要 ..............................................................................................................
2.1.2 臨床試験のコンピテンシー ...................................................................................
国際医療協力局（BIHC） ..........................................................................................................
研究所 熱帯医学・マラリア研究部 ......................................................................................
臨床試験実施施設の経験について : マヒドン大学 熱帯医学部 ........................................
国際感染症センター（DCC） ...................................................................................................
臨床研究センター データサイエンス部 ..............................................................................
ナショナルセンター・バイオバンクネットワーク（NCBN） ..............................................
医薬品安全性監視 (PV) に関する講義 ...................................................................................

15
15
15
16
17
17
18
19
19
20

NCGM 外のプログラム ..............................................................................................................................................
3.1
3.2
3.3
3.4
3.5
3.6
3.7
		
		

医薬品医療機器総合機構（PMDA） ........................................................................................
シオノギ製薬株式会社 .............................................................................................................
国立がん研究センター（NCC） ...............................................................................................
大阪大学医学部附属病院 .........................................................................................................
国際協力機構 .............................................................................................................................
日本 ACRP .................................................................................................................................
科学館 / 博物館 .........................................................................................................................
3.7.1 日本科学未来館 “Miraikan” ..................................................................................
3.7.2 Daiichi Sankyo くすりミュージアム ...................................................................

15

21

21
22
22
23
25
25
26
26
26

4.

公開プレゼンテーションセッション .........................................................................................................................

27

5.

結語 ...............................................................................................................................................................................

28

今後に向けて ....................................................................................................................................................................... 294

別添 ......................................................................................................................................................................................
別添 1 インターナショナルトライアル部 バナー .........................................................................

60

別添 2 スケジュール ........................................................................................................................

61

別添 3

.................................................................

62

		
		

1. Challenge and Suggestions on Drug or Device Developmentin the Democratic Republic of the Congo (DRC) ...............................................

62

		

2.

Challenge and Suggestions on Drug or Device Development in Indonesia ..

66

		
		

3. Challenge and Suggestions on Drug or Device Developmentin the Philippines .......................................................................................................

74

		

4. Challenge and Suggestions on Drug or Device Development in Thailand ...

79

		

5. Challenge and Suggestions on Drug or Device Development in Vietnam ....

85

公開プレゼンテーションセッション発表資料

			
			

			
			
			

Mboloko Mata Junior / Nsengi Ntamabyaliro

Maria Lawrensia Tampubolon / Melva Louisa Simbolon / Dina Nilasari

Maria Elizabeth Mercado / Jay Ron O. Padua / Gelza Mae Almario Zabat
Suvimol Niyomnaitham / Noppadon Tangpukdee / Weerawat Kiddee

Ngo Van Cong / Thi Hong Linh Le

59

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

5

序文

日本とアジア・アフリカ諸国での国際共同臨床試験（Multi-regional Clinical Trial (MRCT））の実施にむけて、信頼のおける安定したネットワークを構築することは NCGM 臨床研究センターインターナショナルトライアル部とアジア・アフリカ各国の連携施設の協力において非常に重要な位置づけとなっています。
MRCT を国際的な基準や手順に従って実施するための、専門家の能力向上に寄与するこのプログラムは、MRCT による新しい薬剤や医療機器の開発を通じて国際的な医療環境の改善に貢献する、という当部署の目的を成し得るための大きな柱の一つといえます。
2018 年度と同様に、コンゴ民主共和国、インドネシア、フィリピン、タイ、ベトナムの 5 カ国より研修生を迎えると共に、今年度は日本の機関からも研修生をお迎えすることができました。昨年度は 10 施設より研修生にお越しいただいた一方で、今年度は 14 の連携施設から当プログラムにご参加いただいたことに感謝いたします。
14 日間のプログラムにおいて研修生は、規制当局（独立行政法人 医薬品医療機器総合機構（PMDA））、民間企業（シオノギ製薬株式会社）、国際協力機構（JICA)、教育機関（大阪大学）、日本 ACRP（Association of Clinical Research
Professionals Japan Chapter）、ナショナルセンターバイオバンクネットワーク（NCBN）、臨床施設（国立がん研究センター（NCC）、
国立国際医療研究センター (NCGM)）で講義や施設の視察を中心としたプログラムに参加しました。
講師の皆様、5 カ国から 2-3 人 / 国の研修生と日本人研修生を合わせた 14 人の研修生、DIT のスタッフ含め、活発に意見交換をすることができたことも、本プログラムで成し得たことの一つです。
今回のプログラムを成功に導いてくださった皆様に感謝するとともに、この活動が今後も継続し、発展しながら各連携国との協業につながるものと期待いたします。

								2020 年 3 月 10 日								国立国際医療研究センター								国立国際医療研究センター病院長																							

6

杉山

温人			

謝辞

薬剤の開発プロセスが複雑化する中において、研究参加者の安全性と権利を確保した上で質の良いデータを得ることは必須要件であり、効果的かつ専門的な研修を受け、十分な能力を有する臨床研究の専門家は質の高い臨床研究の実施において非常に重要な役割を果たします。
国際的な医療状況を改善するべく、連携各国と協力しながら国際共同臨床試験を推進するにあたり、継続性は重要な意味を持っています。NCGM 臨床研究センターインターナショナルトライアル部は、第 2 回目の “A program
focused on comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials
in Asian and African countries” を 2019 年度のプログラムとして実施いたしました。
本プログラムではコンゴ民主共和国、インドネシア、フィリピン、タイ、ベトナムの連携 5 カ国に加え日本からも研修生を迎え、14 日間に渡り講義・施設への視察を実施しました。プログラムの最終的な目的は、新興・再興感染症、
希少疾患、非感染性疾患、難治性疾患等で苦しむ世界中の患者さんに新しい薬剤や診断機器を届けることです。
本事業の実現は、日本及び各連携国の関係者の皆様の多大なるご協力・ご尽力の賜物です。プログラム参加研修生に講義見学の機会を与えてくださいました PMDA の皆様にも感謝を申し上げます。
また、お忙しい中、ご講義や施設見学の機会をご提供くださいました以下の機関・ご担当者の方々に御礼を申し上げます。
【ご協力いただいた機関・法人】
国立がん研究センター中央病院 / シオノギ製薬株式会社 / 大阪大学医学部附属病院 /独立行政法人 国際協力機構 / 独立行政法人 医薬品医療機器総合機構 / 日本 ACRP /ナショナルセンターバイオバンクネットワーク「団結は力なり」という言葉の通り、このプログラムを共に作り上げてくださった NCGM の皆様、とりわけ国際医療協力局、国際感染症センター、熱帯医学・マラリア研究部、データサイエンス部、バイオバンクの皆様、誠にありがとうございました。
最後に、連携各国より研修生をご推薦くださった機関の皆さまに感謝申し上げます。非常に熱心な研修生をお迎えし、このプログラムを成功裏に終了することができましたのも、皆様のご助力なしには実現しえなかったことと確信しております。
【各国における連携施設】（国名のアルファベット順）••

The Democratic Republic of the Congo: University of Kinshasa, Institut National de Recherche Biomédicale
Indonesia: University of Indonesia, Sulianti Saroso Infectious Diseases Hospital, Mochtar Riady ResearchInstitute•

The Philippines: University of the Philippines, St. Luke's Medical Center, San Lazaro Hospital•Thailand: Faculty of Tropical Medicine and Siriraj Hospital in Mahidol University, Prince of Songkla University•

Vietnam: Cho Ray Hospital, Bach Mai Hospital											2020 年 3 月 10 日								国立国際医療研究センター								インターナショナルトライアル部長								臨床研究センター										

飯山

達雄Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

7

略語一覧

ACR

ACRP

ASEAN

ATC

BIHC

CCS

COVID-19

CPF

CRC

DCC
DIT
DRC
FY
8

Academic Clinical Research Center of
Osaka University Hospital
大阪大学医学部附属病院
未来医療開発部 臨床研究センター
Association of Clinical Research
Professionals
エイ・シー・アール・ピー（ACRP)

GCP

ICH

INRB

Asia Training Center
アジア医薬品・医療機器
トレーニングセンター

IPS

Bureau of International Health
Cooperation

IRB

国際医療協力局
Center for Clinical Sciences

IVR

臨床研究センター

JICA

Coronavirus Disease 2019

JTF

新型コロナウイルス感染症（COVID-19）

MRCT

Cell Processing Facility
細胞調整施設Clinical Research Coordinator
治験コーディネーター
Disease Control and Prevention Center
国際感染症センター
Department of International Trials
インターナショナル トライアル部

MTR

NCBN
NCC

NCGM

Democratic Republic of the Congo
コンゴ民主共和国
Fiscal Year
会計年度

医薬品の臨床試験の実施の基準
The International Council for
Harmonisation of TechnicalRequirements for Pharmaceuticals
for Human Use
医薬品規制調和国際会議

Association of Southeast Asian
Nations
東南アジア諸国連合

Good Clinical Practice

PMDA
PV

Institut National de Recherche
Biomédicale
コンゴ民主共和国にある
国立生物医学研究所

Induced Pluripotent Stem Cells（iPS Cells）
人工多能性幹細胞（iPS 細胞）
Institutional Review Board
治験審査委員会

Interventional Radiology
インターベンショナル・ラジオロジー（画像下治療）Japan International Cooperation Agency
独立行政法人 国際協力機構
Joint Task Force
共同タスクフォースMulti-Regional Clinical Trials
国際共同臨床試験
Medical Center for Translational
Research, Osaka University Hospital
大阪大学医学部附属病院
未来医療開発部 未来医療センター
National Center Biobank Network
ナショナルセンター・バイオバンク
ネットワークNational Cancer Center Japan
国立研究開発法人
国立がん研究センター
National Center for Global Health andMedicine
国立研究開発法人
国立国際医療研究センター
Pharmaceuticals and Medical Devices
Agency
独立行政法人医薬品医療機器総合機構
Pharmacovigilance
医薬品安全性監視

図表目次

番号

表題

ページ番号

図1

a.
b.
c.
d.

インターナショナルトライアル部の紹介
日本の暮らし紹介
インターナショナルトライアル部のネットワーク
日本でのごみの処理方法

15

図2

a.
b.
c.

臨床試験のコンピテンシー紹介
臨床試験のコンピテンシーディスカッション
臨床試験のコンピテンシー領域

16

図3

a.
b.
c.

国際医療協力局の活動の紹介
国際医療協力局担当者と集合写真
NCGM のネットワーク

図4

a.
b.

熱帯医学・マラリア研究部の活動紹介
マラリア診断法の紹介

17

図5

a.
b.
c.
d.

マヒドン大学による試験責任医師の役割紹介
インターナショナルトライアル部によるタイのプロジェクト紹介
試験責任医師とはNCGM のタイにおけるプロジェクトの枠組み

18

図6

a.
b.

国際感染症センターの活動の一例
国際感染症センターによる様々な取り組みの紹介

19

図7

a.
b.

NCGM のデータマネージメント体制紹介
データサイエンス部担当者とのディスカッション

19

図8

a.
b.
c.
d.

NCGM バイオバンク見学
ナショナルセンターバイオバンクネットワーク
NCBN カタログデータベース
NCGM バイオバンク

20

図9

a.
b.

コンゴ民主共和国 研修生によるプレゼンテーション
コンゴ民主共和国の医薬品安全性監視 (PV) 体制

20

図 10

PMDA にて22

図 11

シオノギ医薬研究センター前にて

22

図 12

a.
b.
c.
d.
e.

NCC 医師によるプレゼンテーション -1
NCC 医師によるプレゼンテーション -2
NCC のネットワーク
NCC の先生方とディスカッション
NCC の先生方と集合写真

23

図 13

a.
b.
c.
d.
e.
f.

大阪大学医学部附属病院 国際臨床研究体制の紹介
未来医療開発部の紹介
大阪大学医学部附属病院 医師によるプレゼンテーション -1
大阪大学医学部附属病院 医師によるプレゼンテーション -2
大阪大学医学部附属病院 医師によるプレゼンテーション -3
未来医療センター前にて

24

16-17

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

9

番号

表題

図 14

a.
b.

JICA の協力活動の例
JICA ご担当者によるプレゼンテーション

25

図 15

a.
b.

ACRP の紹介
ACRP- Japan のご担当者の皆様

25

図 16

a.
b.

見学の様子 -1
見学の様子 -2

26

図 17

a.
b.

見学の様子
博物館玄関にて集合写真

26

図 18

公開プレゼンテーションセッションの案内

番号

10

ページ番号

表題

表１

研修生プロフィール

表２

PMDA-ATC MRCT Seminar プログラム

27

ページ番号
12-14
21

1.

1.

1.1

はじめに

■

はじめに

研修概要

“A program focused on comprehensive and collaborative training on medical innovations adapted to challenges
of clinical trials in Asian and African countries, 2nd edition" は 国 際 共 同 臨 床 試 験（Multi-regional Clinical Trials（MRCT））の実施にむけて信頼のおける強固なネットワークを構築するため NCGM 臨床研究センターインターナショ
ナルトライアル部が実施した、連携 5 カ国と日本の臨床試験専門家を育成する 14 日間の研修プログラムです。
本年は、コンゴ民主共和国（2 名）、インドネシア（3 名）、フィリピン（3 名）、タイ（3 名）、ベトナム（2 名）の5 カ国に加えて日本国内の施設からも研修生（1 名）をお迎えすることができました。本プログラムでは、独立行政法人医薬品医療機器総合機構アジアトレーニングセンターが実施する国際共同治験セミナー 2020 を見学する機会を頂き、国際共同治験によって得られたデータに対する調和のとれた審査について規制当局の基本的な考え方を知ることができました。革新的な研究や医療技術の現状を知るため、臨床施設（国立がん研究センター (NCC)、国立国際医療研究センター（NCGM)）、教育機関（大阪大学）、民間企業（シオノギ製薬株式会社）で講義や施設の見学視察を中心としたプログラムに参加しました。
国際協力機構（JICA）からは日本の医療協力とプロジェクトの予算配分などについて、臨床試験専門家のための団体である日本 ACRP からは組織の役割とその重要性について講義をして頂きました。本プログラムでは、ASEAN
諸国やアフリカにおける医薬品・医療機器の開発の際の課題や提言をテーマとした公開プレゼンテーションセッ
ションも計画していました。NCGM 内部からの参加者に加え、外部からも 40 名を超える参加登録がありましたが、COVID-19 の流行状況を鑑みて中止となりました。
プレゼンテーション資料は参加登録くださった皆様にお送りするとともに、DIT のホームページにて公開いたします。

1.2

研修の目的

本研修の目的は以下の通りです。
•

日本とパートナー国との間で世界標準の MRCT を実施するためのグローバルな臨床試験ネットワークを確
立する

•

1.3

臨床試験を設計および実施できる専門家を育成する

研修生の背景ASEAN4 カ国、アフリカ 1 カ国、日本、の計 14 施設より医師・薬剤師であり臨床研究の経験のある方々が参加されました。研修生のプロフィールを表 1 に示しています。

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

11

表１

研修生プロフィール

The Democratic Republic of the Congo
Nsengi Yumva Pierre-Michel Ntamabyaliro[Current position]
Study site coordinator, Co-Principal Investigator
INRB
Lecturer at University of Kinshasa, Pharmacovigilance Unit
[Degree(s)]MD, MSc Specialty: Pharmacovigilance and Pharmacoepidemiology
Mata Junior Mboloko[Current position]
Lecturer at University of Kinshasa,
Consultant at Department of Obstetrics and Gynecology
University of Kinshasa[Degree(s)]MD, MSc
Specialty: Obstetrics and Gynecology

VietnamThi Hong Linh Le[Current position]
Consultant at Center for Tropical Diseases, Bach Mai Hospital[Degree(s)]MD,MScSpecialty: Infectious and Tropical Diseases

Ngo Van Cong
[Current position]
Consultant at Department of Otorhinolaryngology- Head and Neck Surgery, Cho
Ray Hospital[Degree(s)]MD, PhD
Specialty: Otorhinolaryngology

Indonesia
Maria Lawrensia Tampubolon[Current position]
Consultant at RSPI Prof. Sulianti Saroso Hospital
External Research Coordinator in Research Unit
RSPI Prof. Sulianti Saroso Hospital[Degree(s)]MD,Specialty: Neurology
12

1.

はじめに

■

Indonesia
Melva Louisa Simbolon[Current position]
Research coordinator, Department of Pharmacology and Therapeutics,
Secretary for Doctoral Program in Biomedical Sciences, Faculty of Medicine
University of Indonesia[Degree(s)]Pharmacist, MSc, PhD
Specialty: Pharmacology
Dina Nilasari[Current position]
Staff and lecturer, Department of Internal Medicine Hasanuddin University
Teaching Hospital
Mochtar Riady InstituteConsultant at Outpatient Clinic Nephrology-Hypertension Unit, Wahidin
Sudirohusodo and Hasanuddin University Hospital[Degree(s)]MD, PhD
Specialty: Internal Medicine, Nephrology

Philippines
Maria Elizabeth Panlaqui Mercado[Current position]
Lead faculty for Biostatistics and Instructor of Clinical Epidemiology, University ofSanto Tomas Faculty of Medicine
University of the Philippines[Degree(s)]MD, Masters in Advance Study (MAS)Specialty: Clinical Research

Gelza Mae Almario Zabat[Current position]
Consultant at St. Luke's Medical Center
St. Luke’s Medical Center[Degree(s)]MDSpecialty: Internal Medicine - Infectious Diseases

Jay Ron Olegario Padua[Current position]
Consultant at San Lazaro Hospital[Degree(s)]MDSpecialty: Pediatric Infectious Diseases

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

13

Thailand
Weerawat Kiddee[Current position]
Associate Professor of Ophthalmology, Glaucoma Unit
Deputy Head of Department for Research, Department of Ophthalmology
Faculty of Medicine, Prince of Songkla University[Degree(s)]MDSpecialty: Ophthalmology

Noppadon Tangpukdee[Current position]
Associate Professor Department of Clinical Tropical Medicine, Faculty of Tropical
Medicine, Mahidol University[Degree(s)]B.N.S. (Nursing and Midwifery)MSc (Medical Toxicology)
Diploma (Medical Microbiology)
PhD (Tropical Medicine)
Suvimol Niyomnaitham[Current position]
Consultant Siriraj Clinical Research Center (SiCRC)
Lecturer and researcher at Department of Pharmacology
Principal Investigator in clinical trials and bioequivalence studies
Faculty of Medicine, Siriraj Hospital, Mahidol University[Degree(s)]MD
MSc (Clinical Epidemiology and Biostatistics)
PhD (Pharmacoepidemiology)
Diploma on Research and Development of products to meet Public Health Needs

Japan
Chisa Tabata[Current position]
Associate Professor Center for Global Health, Department of Medical Innovation,
Osaka University Hospital[Degree(s)]MD, PhD
Specialty: Obstetrics and Gynecology, Medical Genetics

14

2.

2.

NCGM 内のプログラム■

NCGM 内のプログラム

2.1

臨床研究センター

2.1.1

DIT の概要

インターナショナルトライアル部（DIT）

昨年開催の初回プログラムの際と同様に、国際共同臨床試験のプラットフォーム構築・強化するために実施中のプ
ロジェクトを中心に紹介がありました。国際感染症フォーラムの開催等で産官学の情報交換・連携体制を促進し、国際的な医療課題を解決するような共同開発プロジェクトを生み出す取り組みとともに、新興国で国際基準や各国規制を遵守して円滑に国際共同臨床試験を実施する際の DIT の役割の重要性が伝えられました。
アジア・アフリカ各国における臨床試験専門家の能力強化のための継続的なトレーニングプログラム運営は DIT の活動の内の大きな柱の一つであり、重要なものと位置づけられていることについても説明がありました。加えて、実施中の臨床試験についても紹介されました。

2020/1/27

図 1a: インターナショナルトライアル部の紹介

図 1b: 日本の暮らし紹介

How to sort trash

Capacity Building in Each Partner Country

Learn about drug/medical device development and clinical research settings in Japan
which leads to quality in international cooperative clinical research2019 participant countries/institutions
DR Congo
INRB
University of Kinshasa

Short-term training program in 2019 forpartner countries

10 doctors from 5 main

●PMDA Asia Training Center: MRCT seminar 2019
●Visit to clinical trial sites (NCGM・NCC)●Visit to the research laboratory inpharmaceutical company●Visit to regenerative medicine lab（University research lab）
●Open presentation session by trainees: Presented each country’s status
and challenges for clinical research and development

In total, 24 trainees have participated in the program since 2016.
Each country’s trainees who know the actual setting in Japan
have established the network through cross-border partnerships.

Note: You can drink
the tap water in Japan!

Indonesia
University of Indonesia
Sulianti Saroso Hospital
Philippines
University of the Philippines
St. Luke’s Medical Center
Thailand
Mahidol University
Prince of Songkla University
VietnamBach Mai Hospital
Cho Ray Hospital23© 2018 National Center for Global Health and Medicine

623

図 1c: インターナショナルトライアル部のネットワーク

2.1.2

図 1d: 日本でのごみの処理方法

臨床試験のコンピテンシー

Innovation for Global Health

臨床試験のコンピテンシー（専門的能力）のための共同タスクフォース (JTF) は、臨床研究に関わる全ての専門家のコンピテンシーを定義し、その基準を一つの枠組みとして取りまとめた「臨床研究専門職のための調和のとれたコアコ
ンピテンシーの枠組み」を 2014 年に発表し、2018 年に改訂しました。改訂版では 47 のコンピテンシーを 8 つの領域に分類して枠組み化し、それぞれのコンピテンシーにおいて基礎、中級、上級それぞれのレベルを定義しています。8

Thank youComprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition24

15

つの領域は、1. 科学的概念と研究デザイン、2. 倫理面および被験者の安全への配慮、3. 治験薬の開発および規制、4. 臨
床試験の実施（Good Clinical Practice: GCP）
、5. 試験および施設の管理、6. データマネジメントとインフォマティクス（情報科学）、7. リーダーシップと専門性、8. コミュニケーションとチームワーク、から構成されています。DIT の講師が、この枠組みの主な内容を紹介し、なぜ臨床研究の領域においてこのような枠組みが重要となるのか説明しました。中でも、主に領域 1, 2, 4, 5, 6 についてディスカッションを行い、例えば重篤な有害事象 / 有害事象の報告や被験者負担軽減費などについて各国間での現状を共有し比較をするなど、研修生の様々な経験に基づいた意見交換をすることができました。
研修生の多くは、原理原則を遵守しながら、複雑なデザインの試験や被験者個別の状況にどのように対応していくかということに難しさを感じていることがわかりました。このようなディスカッションを続けること自体が、研究の効率的なデザインと適切な実施に向けて重要であると考えられます。
■ JOINT TASK FORCE FOR CLINICAL TRIAL COMPETENCY: https://mrctcenter.org/clinical-trial-competency/

Dr. Noppadon Tangpukdee, Faculty of Tropical
Medicine, Mahidol University, Thailand からのコメント：“ 臨床試験に携わるにあたり核となる専門的能力をCompetency wheel by Joint Task Force for Clinical
Trial Competency of Harvard MRCT center

深めるため、考え方やその能力を身に付けるための方法について学びました。互いの経験を共有し、共に理解を深め、そして講師からはとても有益なコメ

Muchanga Sifa Marie Joelle MD, PhD

ントをもらうことが出来ました。”

Narita Chie, RN, ACRP-CCRA

図 2a: 臨床試験のコンピテンシー紹介

Competency domains for the Clinical Research
Professional
8
domains

3 levels of skills (A,B,C)
47 core competency
statements

(A)
(B)
(C)

© 2018 National Center for Global Health and Medicine

図 2b: 臨床試験のコンピテンシーディスカッション

2.2

図 2c: 臨床試験のコンピテンシー領域

国際医療協力局（BIHC）

NCGM は BIHC を通して、40 年を超える国際協力の歴史を築き、技術協力事業から政策提言まで、幅広く活動を行っています。
技術協力事業の主なものとしては人材育成 ( 看護師やその他の医療従事者への教育、医療技術移転 )、病院マ
ネジメント、などが挙げられます。このような事業は様々な医療問題の解決や医療ニーズの充足に寄与します。
加えて、BIHC は政策の策定に際して助言を行うため、様々な国に職員を派遣してきました。
16

図 3a: 国際医療協力局の活動の紹介

5

2.

NCGM 内のプログラム■

また、コンゴ民主共和国におけるエボラウィルス病の流行において検疫所での管理体制をサポートするために日本の医師を派遣するなど、疾病の流行地域に専門家を派遣する国際的な対応としての活動にも参加している事が紹介されました。

Technical Cooperation
Projects

Afghanistan

Pakistan

India

Nepal

Egypt

Mongolia

Butan

China

Laos

Honduras
Yemen

BrazilBolivia

Viet Nam

SenegalCambodia

Democratic Republic of the Congo

Indonesia

Zambia11

Bangladesh Myanmar Thailand
Zimbabwe Madagascar

図 3b: 国際医療協力局担当者と集合写真

2.3

研究所

図 3c: NCGM のネットワーク

熱帯医学・マラリア研究部

NCGM 研究所熱帯医学・マラリア研究部は、マラリア学を中心とする熱帯医学の研究成果をもって、グローバルヘ
ルスに貢献することを所掌としています。
講義では、さまざまな活動や国際保健協力ネットワークが紹介され、具体例としては、ラオスパスツール研究所やマヒドン大学との協力関係などが挙げられました。
特に、無症候性マラリアの検出のための複数の診断機器に関する研究はマヒドン大学との協力関係を基礎とし、DIT も参加して実施されています。DIT の担当スタッフからも、本研究における DIT の役割と機能についての説明がありました。

Characteristics of the malaria diagnostic tests

SensitivityTimerequiredField
friendliness

図 4a: 熱帯医学・マラリア研究部の活動紹介

2.4

図 4b: マラリア診断法の紹介

臨床試験実施施設の経験について : マヒドン大学

熱帯医学部

試験の実施においては、最低限の実施要件を満たしながら、安全性と有効性を適切に評価することが重要である一方
で、それぞれの施設や試験によって、状況は様々です。臨床試験の専門家は倫理面や規制面から試験固有、依頼者特有のものまで、様々な要件を満たした上で試験を実施する必要があり、その過程においては多くの課題に直面することとなります。
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition17

タイから参加した研修生に講師となって頂き、試験実施施設としてのマヒドン大学の紹介の後、課題に直面した経験などを共有して頂きました。試験責任医師としての経験に基づき、プロトコルの作成から試験結果の論文発表まで、責任医師としての役割について述べて頂き、研修生同士のディスカッションを実施しました。
Dr. Maria Lawrensia Tampubolon, Sulianti Saroso Infectious Diseases Hospital, Indonesia からのコメント：“ マラリア撲滅には、その診断、そして治療、という課題が存在します。それぞれの国が持つ資源を活用して共に前進、協調していくことがとても大切です。”

図 5a: マヒドン大学による試験責任医師の役割紹介

図 5b: インターナショナルトライアル部によるタイのプロジェクト
紹介

Framework
DIT•

Research funding•

Investigational products•••

Automated Hematology
Analyzer
Malaria LAMP Kit

Document Reviews (e.g.
Protocol, Procedure)

Study site

SponsorCollaborators

•
•
•
•
•
•
•
•
•
•

Protocol Development
Document Reviews (e.g.
Protocol, Procedure)
Regulatory and EthicalObligation
Project Management
Site Visits and Study
Monitoring
Quality Management
Data Management
Reporting of Safety Data
Study Budget
Study Cooperation

MOU•

Study implementation•

Document Reviews (e.g.
Protocol, Procedure)•

IRB Correspondence•

Reporting of Safety Data•

Analyze the data

© 2018 National Center for Global Health and Medicine

図 5c: 試験責任医師とは

2.5

22

図 5d: NCGM のタイにおけるプロジェクトの枠組み

国際感染症センター（DCC）

DCC では講義と施設の見学が実施されました。中国での COVID-19 の流行を鑑み、DCC の活動の中でも特に感染症に関する日本の規制や緊急対応の枠組みに焦点を当て、講義が行われました。DCC は、高度な隔離病室や職員への研修、緊急対応チームの構築、初期対応の手順の標準化などについて、経験に基づいた取り組みと改善を行ってきました。研修生は特に DCC の、感染制御への対応に的を絞った職員への初期研修と継続研修に興味を示していました。
ディスカッションは、適切な研修を受けた職員が常時対応できるような管理体制を維持するため、職員の交代時はどのように対応しているかなどにも及びました。
施設見学では、高度隔離病室を訪問しました。緊急時には集中治療を実施することができると同時に、隔離中の患者さんの快適性を維持することを考慮した設備となっている旨、説明を受けました。
Dr. Antonio Villanueva, Department of International Trials, NCGM, the Philippines からのコメント：“ 講義は幾度か中断されることがありました。COVID-19 がまさに日本に上陸したタイミングだったからであり、研修生は歴史的場面に立ち会うこととなりました。大曲先生は今も日本のコロナ対策の先頭に立って指揮を執っています。研修生は皆、無事に本国へ帰国しました。”
18

2.

図 6a: 国際感染症センターの活動の一例

2.6

臨床研究センター

NCGM 内のプログラム■

図 6b: 国際感染症センターによる様々な取り組みの紹介

データサイエンス部

データの質の確保は臨床現場で使用するエビデンスを構築する際の必須要件です。最新の公開論文を例に、基準化した電子データ収集システムをいくつかご紹介頂きました。使用するシステムの選定方法やデータの構築方法は研究者の考え方によって異なりますが、研究者とデータサイエンティストの緊密なコミュニケーションがより質の高いデータを得るための「要」となることは、研究者である研修生の心に残るメッセージとなりました。
Dr. Weerawat Kiddee, Prince of Songkla University, Thailand からのコメント：“（研究における）国際協調体制を構築しそして展開していくには、臨床データを管理する標準的ツールが必要である、との認識を新たにしました。”

図 7a: NCGM のデータマネージメント体制紹介

2.7

図 7b: データサイエンス部担当者とのディスカッション

ナショナルセンター・バイオバンクネットワーク（NCBN）

NCBN は国内 6 ナショナルセンターからなるバイオバンクのネットワークであり、収集される検体の種類は各ナ
ショナルセンターの専門性によって異なります。利用のための問い合わせ窓口は NCBN 事務局で一括して実施されており、ナショナルセンター以外の組織に所属する、国内外の企業を含む研究者も検体の利用申請が可能です。NCBN、
NCGM バイオバンク双方より講師の方々にお越し頂き、NCBN で利用可能な検体数の一覧が確認できる「カタログベース」の使用方法をデモンストレーションして頂きました。
NCGM バイオバンクでは、感染症や代謝疾患、免疫異常等の患者さんの血液などの検体を保管しています。NCGM
バイオバンクへの訪問では、検体の保管状態を厳格かつ詳細に管理している様子を見学することができました。
Dr. Melva Louisa, University of Indonesia, Indonesia からのコメント：“ バイオバンクネットワークを利用した研究は、大きな可能性を秘めていると感じます。”
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

19

Six National Centers - Six diseases-based biobanks
National Center for
Global Health andMedicine (NCGM)

National Center of
Neurology and Psychiatry(NCNP)

Alzheimer diseases
Schizophrenia
EpilepsyHIV
hepatitis B

National Cerebral
andCardiovascularCenter (NCVC)

Ischemic heart diseases
Chronic heart failure

Osaka(⼤阪）

National
CancerCenter (NCC)

Nagoya (名古屋)

CancerNational Centerfor Child HealthandDevelopment
Pregnant women(NCCHD)

National
Center for
Geriatrics andGerontology(NCGG)

Dementias

図 8a: NCGM バイオバンク見学

Tokyo (東京)

New born babies

図 8b: ナショナルセンターバイオバンクネットワーク

NCGM (local) Biobank
The Main Mission of NCGM
NCGM has been confronting the challenges in discovering
the pathology of globally-significant communicable andnon-communicable diseases in order to overcome them.
NCGM Biobank is utilized for:l Detection of disease progression factor and development of easy
diagnostic technology for hepatitis.
l Identification of novel target molecules and detection of biomarkers
for complications.
l Development of innovative, novel anti-hepatitis virus agent.
Samples andclinical info

図 8c: NCBN カタログデータベース

2.8

Utilization

REC (IRB)

図 8d: NCGM バイオバンク

医薬品安全性監視 (PV) に関する講義

コンゴ民主共和国 (DRC) からの研修生より、医薬品安全性監視（PV）の要点の説明に続いて当該国で PV を実施した経験について共有して頂きました。
DRC ではシステム上、保健省にある国立 PV 委員会が PV 業務の取りまとめを行っています。安全性に関する報告を全国から集めた上で、規制当局としての判断をする役割を果たしています。そのために、地域レベルの情報を地域 PV
センターが集め、その情報を全国 PV センターがまとめ、分析し、国立 PV 委員会へ報告します。全国 PV センターはキン
シャサ大学に設置されており医療分野の専門家から成る諮問委員会を有しています。
さらに、北キブ州で発生しているエボラウィルス病の流行中に実施した臨床試験における経験を共有して頂きました。
情勢が安定せず、医療者が一般住民の方々の信頼を十分に得られない環境の中で、多くの国のステークホルダーや機関が

図 9a: コンゴ民主共和国 研修生によるプレゼンテーション

関わる試験において得られた教訓、課題とその解決策についPV system in DRC
Located at the MoHてお話して頂きました。

National PV Commission

Regulatory Authority

Dr. Jay Ron O. Padua, San Lazaro Hospital,

Advisory Committee

National PV Centre

the Philippines からのコメント：“Dr. Nsengi の医薬品安全性監視に関する知識の豊かさは素晴らしいものでした。講義の間、一貫して、仕事に対する熱意とひたむきさを伺うことができました。”
20

Located at the
University of Kinshasa

DSUR,
PBRER

Regional
PV Centres
FP
Healh
Facilities

FP
PHPs

StudiesPopulation

Pharm
Companies

図 9b: コンゴ民主共和国の医薬品安全性監視 (PV) 体制

3.

3.

3.1

NCGM 外のプログラム■

NCGM 外のプログラム

医薬品医療機器総合機構（PMDA）

PMDA と NCGM の包括的連携協定に基づき、PMDA アジア医薬品・医療機器トレーニングセンター（PMDA-ATC）主催の「PMDA-ATC 国際共同治験（MRCT）セミナー 2020」にオブザーバーとしての見学の機会を得ました。本セ
ミナーは規制水準の向上やその調和を促進することを目的として、アジアを中心とした各国規制当局担当者を対象に、国際共同治験をテーマとして取り上げたセミナーです。MRCT の計画・デザイン、実施及び結果の評価における留意点、GCP 調査結果を踏まえた承認審査における留意点、MRCT に基づき承認された医薬品の市販後安全性評価に至るまで、包括的かつ各専門家のご経験や事例に基づいた詳細な講義を聴講しました。特に、PMDA のみならず製薬業
界やアカデミアの先生方からのご講義を聴講することで、より実務に即した形で MRCT についての学びを深めることができました。これは研修生にとって、MRCT の成績がどのように規制当局の評価を受けるのかを理解するよい機会となりました。
表2

セミナープログラム（上記ウェブページより見学したプログラムのみを抜粋 )History of drug evaluation using overseas data in Japan
Scientific insights about ethnic factors<International cooperation and alignment>
Global Platform for Medical Innovation as an Academic Research Organization
Challenges for global cooperation of regulatory agencies<Points to consider when evaluating results>
Statistical consideration for MRCT based on the ICH E17 G/L
PMDA's experiences to review MRCT results<Consideration for MRCT operation>
Practical issues and solutions on MRCT operations (investigator's view point)
Practical issues and solutions on MRCT operations (industry's viewpoint)<Regulatory review based on results of GCP inspection>
How to perform GCP inspection -Role of GCP inspection in review process
How to consider GCP inspection results from reviewer's perspective
Applicant's experiences to undergo GCP inspection<Post market safety evaluation of approved drugs based on MRCT >Global standard for Pharmacovigilance
Risk management plan based on MRCT -industry perspective
Risk management based on MRCT -Regulatory Agency PerspectiveComprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition21

図 10: PMDA にて

3.2

シオノギ製薬株式会社

くすりの研究開発や製造工程についてより広い視点を得ることを目的に、本プログラムでは大阪にあるシオノギ製薬株式会社のシオノギ医薬研究センターを訪問させて頂きました。シオノギ製薬株式会社は「常に人々の健康を守るために必要な最もよい薬を提供する」という理念を基本方針に掲げる、日本を拠点とする製薬会社です。
シオノギグローバルヘルスアクセスポリシーとして、1. アンメットメディカルニーズを満たす革新的な治療法を開発する、2. 医薬品の適正使用を促進する、3. 医薬品が必要な患者さまにとって入手しやすい環境を整備する、4. ヘル
スケアシステムを強化する、が掲げられています。
訪問では、自動フロー合成システムを使用して化合物を合成するデモンストレーションを見学させて頂きました。
研究所やオフィスエリアなど、設備の整った施設ツアーの後には、各専門分野で活躍されている研究員の方々より、承認済みの感染症治療薬を例に、薬剤開発のそれぞれのフェー
ズ ( 早期開発段階から後期臨床試験まで ) における経験や課題についてお話を頂きました。
Dr. Gelza Mae Almario Zabat, St. Luke’s Medical
Center, the Philippines からのコメント：“ シオノギが手掛けている薬の研究開発は目を見張るものばかりでした。”

3.3

図 11: シオノギ医薬研究センター前にて

国立がん研究センター（NCC）

国立がん研究センター (NCC) は日本で一番多くのがんの臨床試験を実施している施設です。NCC においても施設の視察ツアーと臨床試験に関わる専門家の医師からの講義をして頂きました。NCC の概要説明の後には、センターにおける臨床試験の現状と薬剤開発におけるこれまでの実績についてもご紹介頂きました。NCC は今まで、国内臨床試験、国際共同臨床試験の両方を実施してこられましたが、特に国際共同臨床試験においては、文化や言語の違い、規制要件の違いや資金の確保・管理、被験薬の管理など、様々な課題に直面してこられました。特に昨今では、NCC で実施されている臨床試験数に比べた臨床試験コーディネーター (CRC) の不足を補う工夫として、CRC が担当する試験を研究
分野に応じて割り振っているというお話もありました。さらに、着任時の研修と継続研修についても、臨床試験をサポートする際の重要なポイントとしてご紹介頂きました。
22

3.

NCGM 外のプログラム■

施設の視察ツアーでは、フェーズ１臨床試験用の入院施設や外来化学療法センター、内視鏡センター、放射線治療部
門、バイオバンク、IVR センター (Interventional Radiology Center) を見学させて頂きました。
Dr. Suvimol Niyomnaitham, Siriraj Hospital, Thailand からのコメント：“ この機関では、臨床試験が当たり前の事のように行われており、この姿は私が所属する機関において是非手本としたいと思うものでした。”

図 12a: NCC 医師によるプレゼンテーション -1

図 12b: NCC 医師によるプレゼンテーション -2

図 12c: NCC のネットワーク

図 12d: NCC の先生方とディスカッション

図 12e: NCC の先生方と集合写真

3.4

大阪大学医学部附属病院

大阪大学は、日本の高等教育をけん引する国立大学の一つです。大阪大学医学部附属病院の見学では、細胞培養調整施設（CPF）と第Ⅰ相臨床試験施設を訪問させて頂きました。
講義では、以下についてご紹介頂きました。
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition23

•

国際共同臨床研究実施に向けた取り組み•

大阪大学医学部附属病院臨床研究センター (ACR)•

大阪大学医学部附属病院未来医療センター (MTR)

各国の医療事情や IRB/ 倫理委員会の組織について、また将来の協力・協業の可能性と、どのように進めて行くかなど、
多岐にわたる話題についてディスカッションが実施されました。
更に、大阪大学医学部附属病院で医師主導治験として iPS 心筋細胞シートが第１症例目の方に移植され、前日にニュース発表されたことを共有して頂きました。
Dr. Maria Elizabeth Mercado, University of the Philippines, Manila, the Philippines からのコメント：“ 大阪大学の取り組みは、アカデミアにおいて研究を推し進めるために必要な、サポート体制の先駆けとなる例
だと感じます。”

図 13a: 大阪大学医学部附属病院 国際臨床研究体制の紹介

図 13b: 未来医療開発部の紹介

24

図 13c: 大阪大学医学部附属病院 医師によるプレゼンテーション -1

図 13d: 大阪大学医学部附属図 13e: 大阪大学医学部附属病院 医師によるプレゼンテー

病院 医師によるプレゼンテー

ション -2ション -3

図 13f: 未来医療センター前にて

3.

3.5

NCGM 外のプログラム■

国際協力機構国際協力機構 (JICA) は、資金面において世界最大規模の二国間援助を実施する組織の 1 つで、150 をこえる開発途
上国・地域で活動する組織です。
JICA の概要説明の後、JICA が途上国政府と協力して実施されている保健関連の活動についてご紹介頂きました。
医薬品や食品の安全を確保するための市販後の管理システムや研究能力の強化、保健関連のマネジメント強化のための技術協力などが活動例の一部として挙げられました。ディスカッションでは、JICA からの協力を受けるためにはどうすればよいのかなどの話題にも研修生の注目が集まり、JICA は政府間で外交的に提出された正式な要請を基に協力を行っていることが説明されました。また、特に、民間セクターとの協力に関して、研修生からの質問がありました。
Dr. Ngo Van Cong, Cho Ray Hospital, Viet Nam からのコメント：“JICA は数多くの発展途上国を援助しています。的確な、大きな効果をもたらす援助です。”

Examples of Yen Loan

Indonesia: SmallScale Irrigation
Management Project

India: Delhi Mass
Rapid Transport System
Project

Tunisia: Integrated
Reforestation Project

China: Sichuan Higher
Education Project11

図 14a: JICA の協力活動の例

3.6

図 14b: JICA ご担当者によるプレゼンテーション

日本 ACRP

Association of Clinical Research Professionals (ACRP) は米国の首都ワシントンに本部を置き、70 カ国以上に13000 人以上の会員を有する、臨床試験専門家の育成や認定、教育のための非営利組織です。その活動や認定プログ
ラムについて、特に試験責任医師 (PI) に焦点を当てて紹介頂きました。各国にある支部の一つとして、日本支部における教育プログラムや施設の視察、認定試験対策などの活動についてもお話がありました。
Dr. Nsengi Ntamabyaliro, The Institut National de Recherche Biomédicale, DRC からのコメント：“ この組織の存在を知る事が出来、そして研修教材、オンライン教材、オンライン講座、更には様々な資格認定の活動についても知ることが出来たのは大変有意義でした。”
ACRP Global

Organization© Association of Clinical Research Professionals � acrpnet.org

図 15a: ACRP の紹介

図 15b: ACRP- Japan のご担当者の皆様

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25

3.7

科学館 / 博物館

科学の世界、その中でも特に薬剤開発の分野における革新への理解を深めることを目的に、日本科学未来館“Miraikan” と Daiichi Sankyo くすりミュージアムの 2 つの博物館を見学しました。
Dr. Mboloko Mata Junior, University of Kinshasa, DRC からのコメント：” 未来館 “ ではロボットの展示が印象的でした。暮らしをより良くするために科学をいかに活用できるか、という点について学ぶことができ非常に興味深かったです。”

3.7.1

日本科学未来館 “Miraikan”

日本科学未来館 “Miraikan” は、科学、技術への理解を深め、その役割や可能性について考えていくことを目的として作られました。
展示内容は、技術革新、グローバルな環境問題、宇宙、生命科学を含む幅広いテーマにまたがります。研修生たち
は iPS 細胞の研究、人工知能の活用、腹腔鏡手術の進歩など、医療における様々な技術革新について理解を深め、体験し、多くを学ぶことができました。
■

日本科学未来館 “Miraikan” ホームページ : https://www.miraikan.jst.go.jp/

図 16a: 見学の様子 -1

3.7.2

図 16b: 見学の様子 -2

Daiichi Sankyo くすりミュージアム

くすりミュージアムは、広く一般の人々に向けて薬やその開発を身近に感じてもらえるような工夫が凝らされた博物館です。見て聞いて触れて、という双方向型の体験を通じて薬について学ぶことができました。
■

Daiichi Sankyo くすりミュージアム

図 17a: 見学の様子

26

ホームページ : https://kusuri-museum.com

図 17b: 博物館玄関にて集合写真

4.

4.

公開プレゼンテーションセッション■

公開プレゼンテーションセッション

各国の臨床研究 / 臨床試験の現状と課題、医療ニーズ、将来の協力にむけた提案について NCGM 内外の方々に向けて発表する公開セッションを企画していましたが、残念ながら COVID-19 のの流行状況を鑑みて中止となりました。
発表予定のスライド資料については本研修プログラムで講師を務めていただいた皆様、研修生、公開セッションへの参加登録者に共有するとともに、DIT のホームページにて公開する予定です。

Department of International Trials
training network conference

Challenges and suggestions on
drug/device development
in ASEAN & African countries

There is a gap in Research and Development (R&D) between different
countries and regions in the world.
Speakers from five countries including Thailand, Indonesia, Vietnam, The
Philippines and the Democratic Republic of the Congo will present aboutclinical trials conduct at their respective countries from their point of view.
Discussions will focus on future collaboration for clinical research andcomparison with system in Japan.
Everyone involved or interested in clinical research is WELCOME!

Date：January 30, 2020
Time : 10:00 – 12:00（Doors Open at 9:30）
Registration

QR codeVenue: NCGM Research Institute Conference Room AB
Fee: Free（Prior registration required）
Registration: HereContact:
NCGM Department of International Trials Ichikawa/Narita
Language: English
Tel/ 03-6228-0445 Email/ dit-info@hosp.ncgm.go.jp

図 18: 公開プレゼンテーションセッションの案内

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27

5.

結語

昨年に引き続き 2 回目となる本研修においては、5 カ国から 13 名と日本から 1 名の研修生が一堂に会し、14 日間に渡り、MRCT データに対する規制当局の審査の視点や日本での臨床研究・臨床試験の現場の状況、国際医療協力における日本政府の貢献、将来の研究での使用を目的とした検体の適切な保管などについて学びを深めました。加えて、臨床試験の専門家にとって必要な専門的能力は何かを学んだうえで、医薬品の研究開発について現場の状況について知る機会を得ました。
公開プレゼンテーションセッションは中止となりましたが、研修生がプログラムでの学びを生かして作成したスラ
イド資料は講師の皆さま、セッションに参加登録してくださった皆様、研修生で共有し、将来の協力・協業に向けた一歩としての役割を果たすことと期待しています。
■大阪大学医学部附属病院の先生方からのコメント：
田畑先生 :“ 本研修に参加して最も印象的だったのは、研修生、講師、NCGM のコミュニケーションの素晴らしさです。今後の国際共同臨床試験への良好な協調体制を確信しました。”
名井先生 :“ 皆さんが NCGM のこのプログラムを満喫されたことを望みます。”
中谷先生 :“ この研修が皆さんの経験や知識をより豊かにするものとなりますように願っています。”

28

5.

結語

■

今後に向けて2020 年 1 月 に 開 催 し まし た 14 日 間 に 渡 る "A program focused on comprehensive and collaborative training on
medical innovations adapted to challenges of clinical trials in Asian and African countries, 2nd edition" では 5 カ国より13 名に加え、日本からも 1 名の研修生を迎えました。
研修生からは、聴講した PMDA による規制調和の講義や、臨床施設（国立がん研究センター（NCC）、国立国際医療研究センター (NCGM））、教育機関（大阪大学）、国際協力機構（JICA）、日本 ACRP（Association of Clinical Research
Professionals Japan Chapter）、民間企業（シオノギ製薬株式会社）の講義、また様々な議論を通じて他国の状況をも知りえる機会が提供できたことなどに高い評価を得た一方、専門家との具体的な事例を取り上げた議論など、双方向型の研修内容への要望がありました。
今後も、より良いプログラムの実施に向け、関係者の皆様のご指導、ご協力を賜りますよう、引き続きよろしくお願い申し上げます。

								2020 年 3 月 10 日								国立国際医療研究センター								インターナショナルトライアル部長								臨床研究センター										

飯山

達雄Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

29

30

Comprehensive and collaborative training
on medical innovations
adapted to challenges of clinical trials
in Asian and African countries[2nd edition]ENGLISH / 英語Table of Contents

Table of Contents .............................................................................................................................................................. 32
Preface ................................................................................................................................................................................ 34
Acknowledgements ......................................................................................................................................................... 35
List of Acronyms ............................................................................................................................................................... 36
List of Figures and Tables ............................................................................................................................................. 37
1.

Introduction ................................................................................................................................................................ 39
1.1 Description of the Training Program ....................................................................................... 39
1.2 Program Objectives ................................................................................................................... 39
1.3 Participants ................................................................................................................................ 39

2.

Activities at NCGM ...................................................................................................................................................
2.1 Center for Clinical Sciences Department of International Trials (DIT) ............................
		
2.1.1 Overview of DIT ......................................................................................................
		
2.1.2 Clinical Trial Competency ......................................................................................
2.2 Bureau of International Health Cooperation (BIHC) ..........................................................
2.3 Department of Tropical Medicine and Malaria, Research Institute .................................
2.4 Experience from a Clinical trial site: Mahidol University,
Faculty of Tropical Medicine case ..........................................................................................
2.5 Disease Control and Prevention Center (DCC) ....................................................................
2.6 Department of Data Science, Center for Clinical Sciences ................................................
2.7 National Center Biobank Network (NCBN) ...........................................................................
2.8 Lecture on Pharmacovigilance ................................................................................................

3.

43

43
43
43
44
45
45
46
47
47
48

Activities outside of NCGM ..................................................................................................................................... 49
Pharmaceuticals and Medical Devices Agency (PMDA) ....................................................
SHIONOGI & CO., LTD. ............................................................................................................
National Cancer Center Japan (NCC) ....................................................................................
Osaka University Hospital .......................................................................................................
Japan International Cooperation Agency ...................................................................................

49
50
51
52
53

3.7 Science Museum .........................................................................................................................

54

3.1
3.2
3.3
3.4
3.5

3.6 Association of Clinical Research Professionals, Japan Chapter ..............................................

		
		

3.7.1
3.7.2

National Museum of Emerging Science and Innovation: “MIRAIKAN” .........
Daiichi Sankyo Medicine Museum: “KUSURI MUSEUM” ...............................

54

55
55

4.

Open presentation session ..................................................................................................................................... 56

5.

Conclusion ..................................................................................................................................................................

57

Future Prospects .............................................................................................................................................................. 58

32

Appendix ............................................................................................................................................................................. 59
Appendix 1

Department of International Trials bannerAppendix 2

Training Program Schedule

Appendix 3

Presentation Handouts....................................................... 60................................................................................. 61........................................................................................ 46				

1. Challenge and Suggestions on Drug or Device Developmentin the Democratic Republic of the Congo (DRC) ...............................................

62

		

2.

Challenge and Suggestions on Drug or Device Development in Indonesia ..

66

		
		

3. Challenge and Suggestions on Drug or Device Developmentin the Philippines .......................................................................................................

74

		

4. Challenge and Suggestions on Drug or Device Development in Thailand ...

79

		

5. Challenge and Suggestions on Drug or Device Development in Vietnam ....

85

			
			

			
			
			

Mboloko Mata Junior / Nsengi Ntamabyaliro

Maria Lawrensia Tampubolon / Melva Louisa Simbolon / Dina Nilasari

Maria Elizabeth Mercado / Jay Ron O. Padua / Gelza Mae Almario Zabat
Suvimol Niyomnaitham / Noppadon Tangpukdee / Weerawat Kiddee

Ngo Van Cong / Thi Hong Linh Le

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition33

Preface

The establishment of a reliable and stable network for implementation of Multi-Regional Clinical Trials (MRCT)
among Japan, Asian and African countries is the crucial element of the collaboration between the Center for
Clinical Sciences/Department of International Trials (CCS/DIT) of the National Center for Global Health andMedicine (NCGM) and its partner institutions located in Asia and Africa.
The program for capacity building of health professionals capable of implementing multi-regional clinicalresearches in accordance with internationally standardized procedures is one of the main pillars for theachievement of the CCS/DIT project. This project aims to contribute to the improvement of medical care aroundthe world by affirming new medicines and diagnostic tools through MRCTs.
Same as for the FY 2018 program, delegates from five countries, namely: The Democratic Republic of theCongo, Indonesia, The Philippines, Thailand, and Vietnam participated, while a delegate from Japan was added.
In total, 14 institutions sent representatives to the program compared to 10 previously.
This 14-day training program consisted of lectures and guided visits at Japan’s regulatory authority(Pharmaceuticals and Medical Devices Agency (PMDA)), private industry (SHIONOGI & CO., LTD.), governmental
agency (the Japan International Cooperation Agency (JICA)), academia (Osaka University), the Association ofClinical Research Professionals-Japan chapter (ACRP-JP), the National Center Biobank Network (NCBN), andclinical settings (National Cancer Center (NCC) and NCGM), was a great opportunity for exchange and richdiscussions among the 14 participants (two to three per country), lecturers and DIT staff. The current program
introduced two novel approaches: the participation of a delegate from a Japanese institution and the inclusion of
lectures from some delegates who shared about their experience on pharmacovigilance and clinical trials in theirrespective institutions.
We continuously thank each one who contributed to the achievement of this activity and hope that it willcontinuously grow for cooperation with counterpart countries.

34							

Haruhito Sugiyama							

Director, Center for Clinical Sciences,							

National Center for Global Health and Medicine							March 10, 2020

Acknowledgments

The complexity of drug development process and the impact it has on human health require the generationof good data while paying careful attention to the research participants’ safety and rights. Effective and relevant
training of skilled clinical research professionals plays an essential role in the clinical research quality.

Continuity plays a key role in promoting multi-regional clinical research that contributes to the improvement of

global health in collaboration with counterpart countries. The Center for Clinical Sciences-Department of International
Trials of the National Center for Global Health and Medicine organized the FY2019 training program entitled “The2020 NCGM/CCS country-specific MRCT capacity building: A program focused on comprehensive and collaborative
training on medical innovations adapted to challenges of clinical trials in Asian and African countries, 2nd edition”.

This was 14-days full of intensive lectures and site visits, planned for delegates from Japan and five countries,

namely The Democratic Republic of the Congo, Indonesia, The Philippines, Thailand, and Vietnam. The ultimate
goal of the program is to provide new medical treatment and diagnostic medical devices that will benefit patientswith emerging and re-emerging infectious diseases, rare diseases, non-communicable diseases and intractablediseases around the world.

The accomplishment of this work was the result of the cooperative efforts of many stakeholders within Japan andfrom our partner countries. As such, we sincerely thank the PMDA who kindly provided opportunity to our delegates.

We thank all the organizations and their personnel who, despite their multiple responsibilities, accepted toprovide lectures and/or site visits:•

National Cancer Center Hospital, Japan•

Osaka University Hospital

•
•
•
•

•

SHIONOGI & CO., LTD.

Japan International Cooperation Agency

Pharmaceuticals and Medical Devices Agency

Association of Clinical Research Professionals, Japan Chapter
The National Center Biobank Network

Since “unity is strength”, we gratefully thank all NCGM Departments who always come together with us

to make the program a success, namely the Bureau of International Health Cooperation, Disease Control andPrevention Center, Department of Tropical Medicine and Malaria, Data Science Department, and Biobank.

Finally, to those institutions from our counterpart countries who accepted to send their professionals; without

their collaboration, we would not have such dedicated participants who were definitely the key to make thisprogram successful. We gratefully thank all of you.

Our international partner institutions are as follows (by alphabetical order of country’s name):•

The Democratic Republic of the Congo: University of Kinshasa, Institut National de Recherche Biomédicale•

The Philippines: University of the Philippines, St. Luke's Medical Center, San Lazaro Hospital

•

•

•

Indonesia: University of Indonesia, Sulianti Saroso Infectious Diseases Hospital, Mochtar Riady ResearchInstituteThailand: Faculty of Tropical Medicine and Siriraj Hospital in Mahidol University, Prince of Songkla University
Vietnam: Cho Ray Hospital, Bach Mai Hospital							

Tatsuo Iiyama																												

Director, Department of International Trials,
Center for Clinical Sciences,
National Center for Global Health and Medicine
March 10, 2020

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

35

List of Acronyms

ACR

Academic Clinical Research Center of Osaka University Hospital

ACRP

Association of Clinical Research Professionals

ASEAN

Association of Southeast Asian Nations

ATC

Asia Training Center

BIHC

Bureau of International Health Cooperation

CCS

Center for Clinical Sciences

COVID-19

Coronavirus Disease 2019

CPF

Cell Processing Facility

CRC

Clinical Research Coordinator

DCC

Disease Control and Prevention Center

DIT

Department of International Trials

DRC

Democratic Republic of the Congo

FY

Fiscal Year

GCP

Good Clinical Practice

ICH

36

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use

INRB

Institut National de Recherche Biomédicale

IPS

Induced Pluripotent Stem Cells（iPS Cells）

IRB

Institutional Review Board

IVR

Interventional Radiology

JICA

Japan International Cooperation Agency

JTF

Joint Task Force

MRCT

Multi-Regional Clinical Trials

MTR

Medical Center for Translational Research, Osaka University Hospital

NCBN

National Center Biobank Network

NCC

National Cancer Center JapanNCGM

National Center for Global Health and Medicine

PMDA

Pharmaceuticals and Medical Devices Agency

PV

PharmacovigilanceList of Figures and Tables

Number

Title

Page No.

Fig. 1

a.
b.
c.
d.

DIT presentation
Introduction of life in JapanThe DIT network
Garbage management in Japan

43

Fig. 2a.
b.
c.

Competency wheel presentation
Discussion during the competency wheel presentation
Competency domains for clinical research professionals

44

Fig. 3a.
b.
c.

BIHC presentation; BIHC’s activities
Group photo with the BIHC representative
NCGM’s collaboration network

Fig. 4a.
b.

Department of Tropical Medicine and Malaria presentation
Malaria diagnostic tests available at the NCGM

45

a.
b.
c.
d.

Mahidol University delegate presentation; Responsibility of Principal
Investigator
DIT presentation; Overview of NCGM DIT’s projects in Thailand
Role of the PI slide from Mahidol University
NCGM’s Thai projects framework

46

Fig. 6a.
b.

DCC’s activities
DCC presentation

Fig. 7a.
b.

Data management system in the NCGM
Discussion with Data Science Department representative

Fig. 8

a.
b.
c.
d.

NCGM biobank visit
National Center Biobank Network
NCBN catalog database portal
NCGM biobank description

Fig. 9a.
b.

DRC delegate presenting the Pharmacovigilance system in DRC
Pharmacovigilance system in DRC

Fig. 10Group photo after PMDA lecture50

Fig. 11

Shionogi Co.Ltd. visit

50

Fig. 12

a.
b.
c.
d.
e.

Fig. 5

NCC presentation -1
NCC presentation -2
The national cancer - care network
Discussion with NCC doctors
Group photo with NCC representatives

44-45

46-47

47

47-48

48

51-52

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition37

Number

Title
a.
b.
c.
d.
e.
f.

Overseas Engagement of Clinical Research to Develop Academic Seeds
Osaka University Hospital Department of Medical Innovation
Osaka University Hospital presentation -1
Osaka University Hospital presentation -2
Osaka University Hospital presentation -3
Group photo in front of the Center of Medical Innovation and Translational
Research

52-53

Fig. 14a.
b.

Example of yen loan by JICA
JICA representative presentation; Introducing JICA activities

53-54

Fig. 15a.
b.

ACRP organization
ACRP - Japan members

54

Fig. 16a.
b.

Miraikan visit -1
Miraikan visit -2

55

Fig. 17a.
b.

Kusuri Museum visit -1
Kusuri Museum visit -2

55

Fig. 18

Open seminar flyer

Fig. 13

Number38

Page No.

56

Title

Page no.

Table 1

Delegates Profiles

40-42

Table 2

PMDA-ATC MRCT Seminar program

49-50

1.

1.

1.1

Introduction■

Introduction

Description of the Training Program

The 2020 NCGM/CCS country-specific MRCT capacity building: “A program focused on comprehensive
and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and Africancountries, 2nd edition" was a 14-day training program which aimed to solidify the international network and to
improve capacity of clinical research professionals from five counterpart countries and Japan in the conduct ofmultiregional clinical research.
This year’s program invited 14 delegates, from The Democratic Republic of the Congo (2), Indonesia (3), The
Philippines (3), Thailand (3), and Vietnam (2) and from Japan (1). The program included lectures, discussions,and visits to the PMDA, a pharmaceutical company, and clinical research facilities.
Participants attended the 2020 Multiregional Clinical Trials (MRCT) Seminar organized by the PMDA Asia
Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) and gained insight into
the harmonization of regulatory review of MRCT data.
In order to know the current status of research and medical innovations, lectures and visits were provided
from the clinical setting (NCGM, NCC), academia (Osaka University), and from a private company (SHIONOGI &CO., LTD).
The representative of the Japan International Cooperation Agency (JICA) lectured about Japanese international
health cooperation and their project financing procedure while the lecturer from the Association of ClinicalResearch Professionals (ACRP) explained the importance and concept of their organization.
A public seminar where delegates were supposed to discuss challenges and suggestions on drug/device
development in ASEAN and African countries was planned. In addition to those from NCGM, 40 participants
registered for this session; however, the session was cancelled due to the outbreak of the COVID-19 since it ismanaged at NCGM’s Center Hospital.
Presentation slides were shared with registrants and uploaded to DIT’s homepage.

1.2

Program Objectives

The program aimed:•

To establish a global clinical research network to conduct global standard MRCTs between Japan andpartner countries.

•

1.3

To build capability of professionals able to design and conduct clinical research.

Participants

Medical doctors and pharmacists from 14 institutions in four South East Asian, one African country and Japan
who have been involved in clinical research participated in the program.
Following in Table 1 are their profiles.
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

39

Table 1. Delegates Profiles

The Democratic Republic of the Congo
Nsengi Yumva Pierre-Michel Ntamabyaliro[Current position]
Study site coordinator, Co-Principal Investigator
INRB
Lecturer at University of Kinshasa, Pharmacovigilance Unit
[Degree(s)]MD, MSc Specialty: Pharmacovigilance and Pharmacoepidemiology
Mata Junior Mboloko[Current position]
Lecturer at University of Kinshasa,
Consultant at Department of Obstetrics and Gynecology
University of Kinshasa[Degree(s)]MD, MSc
Specialty: Obstetrics and Gynecology

VietnamThi Hong Linh Le[Current position]
Consultant at Center for Tropical Diseases, Bach Mai Hospital[Degree(s)]MD,MScSpecialty: Infectious and Tropical Diseases

Ngo Van Cong
[Current position]
Consultant at Department of Otorhinolaryngology- Head and Neck Surgery, Cho
Ray Hospital[Degree(s)]MD, PhD
Specialty: Otorhinolaryngology

Indonesia
Maria Lawrensia Tampubolon[Current position]
Consultant at RSPI Prof. Sulianti Saroso Hospital
External Research Coordinator in Research Unit
RSPI Prof. Sulianti Saroso Hospital[Degree(s)]MD,Specialty: Neurology
401.

Introduction■

Indonesia
Melva Louisa Simbolon[Current position]
Research coordinator, Department of Pharmacology and Therapeutics,
Secretary for Doctoral Program in Biomedical Sciences, Faculty of Medicine
University of Indonesia[Degree(s)]Pharmacist, MSc, PhD
Specialty: Pharmacology
Dina Nilasari[Current position]
Staff and lecturer, Department of Internal Medicine Hasanuddin University
Teaching Hospital
Mochtar Riady InstituteConsultant at Outpatient Clinic Nephrology-Hypertension Unit, Wahidin
Sudirohusodo and Hasanuddin University Hospital[Degree(s)]MD, PhD
Specialty: Internal Medicine, Nephrology

Philippines
Maria Elizabeth Panlaqui Mercado[Current position]
Lead faculty for Biostatistics and Instructor of Clinical Epidemiology, University ofSanto Tomas Faculty of Medicine
University of the Philippines[Degree(s)]MD, Masters in Advance Study (MAS)Specialty: Clinical Research

Gelza Mae Almario Zabat[Current position]
Consultant at St. Luke's Medical Center
St. Luke’s Medical Center[Degree(s)]MDSpecialty: Internal Medicine - Infectious Diseases

Jay Ron Olegario Padua[Current position]
Consultant at San Lazaro Hospital[Degree(s)]MDSpecialty: Pediatric Infectious Diseases

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

41

Thailand
Weerawat Kiddee[Current position]
Associate Professor of Ophthalmology, Glaucoma Unit
Deputy Head of Department for Research, Department of Ophthalmology
Faculty of Medicine, Prince of Songkla University[Degree(s)]MDSpecialty: Ophthalmology

Noppadon Tangpukdee[Current position]
Associate Professor Department of Clinical Tropical Medicine, Faculty of Tropical
Medicine, Mahidol University[Degree(s)]B.N.S. (Nursing and Midwifery)MSc (Medical Toxicology)
Diploma (Medical Microbiology)
PhD (Tropical Medicine)
Suvimol Niyomnaitham[Current position]
Consultant Siriraj Clinical Research Center (SiCRC)
Lecturer and researcher at Department of Pharmacology
Principal Investigator in clinical trials and bioequivalence studies
Faculty of Medicine, Siriraj Hospital, Mahidol University[Degree(s)]MD
MSc (Clinical Epidemiology and Biostatistics)
PhD (Pharmacoepidemiology)
Diploma on Research and Development of products to meet Public Health Needs

Japan
Chisa Tabata[Current position]
Associate Professor Center for Global Health, Department of Medical Innovation,
Osaka University Hospital[Degree(s)]MD, PhD
Specialty: Obstetrics and Gynecology, Medical Genetics

42

2.

2.

Activities at NCGM■

Activities at NCGM

2.1

Center for Clinical Sciences Department of International Trials (DIT)

2.1.1

Overview of the DIT

The DIT's project to build a collaborative platform for multi-regional clinical trials was extensively explained
to participants by the DIT representatives. It was explained that DIT promotes information exchange andcooperation among government agencies, companies, and academic institutions by, for example, organizing
international forums on infectious diseases, while supporting the seamless execution of multi-regional clinical
trials in emerging countries in compliance with international standards and country-specific regulations.
In order to develop a better and solid environment for multi-regional clinical trial programs, DIT is continuously
organizing training programs for capacity building of clinical trial professionals in Asian and African countries.

2020/1/27

Fig. 1a: DIT presentation

Fig. 1b: Introduction of life in Japan

How to sort trash

Capacity Building in Each Partner Country

Learn about drug/medical device development and clinical research settings in Japan
which leads to quality in international cooperative clinical research2019 participant countries/institutions

Note: You can drink
the tap water in Japan!

DR Congo
INRB
University of Kinshasa
Short-term training program in 2019 forpartner countries

10 doctors from 5 main

●PMDA Asia Training Center: MRCT seminar 2019
●Visit to clinical trial sites (NCGM・NCC)●Visit to the research laboratory inpharmaceutical company●Visit to regenerative medicine lab（University research lab）
●Open presentation session by trainees: Presented each country’s status
and challenges for clinical research and development

In total, 24 trainees have participated in the program since 2016.
Each country’s trainees who know the actual setting in Japan
have established the network through cross-border partnerships.

Indonesia
University of Indonesia
Sulianti Saroso Hospital
Philippines
University of the Philippines
St. Luke’s Medical Center
Thailand
Mahidol University
Prince of Songkla University
VietnamBach Mai Hospital
Cho Ray Hospital© 2018 National Center for Global Health and Medicine

23

23

Fig. 1c: The DIT network

6

Fig. 1d: Garbage management in Japan

2.1.2

Clinical Trial Competency
Innovation
for Global HealthIn order to achieve a single, high-level set of standards to serve as a framework for defining professional
competency throughout the clinical research enterprise, the Harmonized Core Competency Framework was
released in 2014 and reviewed in 2018 by the Joint Task Force for Clinical Trial Competency (JTF). The later
version defined competencies at Fundamental, Skilled and Advanced levels for the 47 competencies of the 8Thank youComprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition24

43

domains in the framework. The 8 domains comprise: 1.
Scientific Concepts and Research Design, 2. Ethical andParticipant Safety Considerations, 3. Investigational Products

Competency wheel by Joint Task Force for Clinical
Trial Competency of Harvard MRCT center

Development and Regulation 4. Clinical Study Operations(Good Clinical Practice), 5. Study and Site Management,
6. Data Management and Informatics, 7. Leadership andProfessionalism, and 8. Communications and Teamwork. DIT
lecturers shared about the content of the competency wheel
and why it is a nice tool for the clinical research enterprise.

Muchanga Sifa Marie Joelle MD, PhD
Narita Chie, RN, ACRP-CCRA

Fig. 2a: Competency wheel presentation

Discussion was mainly focused towards domains 1, 2,
4, 5, and 6; various experiences were shared. For example,
Serious Adverse Events (SAE)/AE reporting and subject
compensation were compared between countries.
Most participants highlighted difficulties on how to alignwith the principles related to the complexity of the trial
design and the adaptation to each individual situation.
Therefore, discussion remains on how to create an efficientdesign and for appropriate implementation of the research.
■ JOINT TASK FORCE FOR CLINICAL TRIAL COMPETENCY:
https://mrctcenter.org/clinical-trial-competency/

Fig. 2b: Discussion during the competency wheel
presentation
Competency domains for the Clinical Research
Professional
8
domains

3 levels of skills (A,B,C)
47 core competency
statements(A)

Comment from: Dr. Noppadon Tangpukdee, Fauclty of(B)

Tropical Medicine, Mahidol University, Thailand(C)“We have learned about the guidance and tools toensure our professional competency in clinical research.”“We have learned, and we have shared our experience
together and received very good comments from the© 2018 National Center for Global Health and Medicine

Fig. 2c: Competency domains for clinical researchprofessionals

team.”

2.2

Bureau of International Health Cooperation (BIHC)

With more than a 40-year history of international healthcooperation, the NCGM through its BIHC is conducting awide range of technical cooperation projects and policy
proposals.
Technical cooperation projects include human resource
development (e.g., education of nurses and other medical
professionals, medical technology transfer), hospitalmanagement, and these cover many kinds of healthproblems and needs.
In addition, the BIHC has dispatched their staff indifferent countries to provide health-related counselling topolicymakers.
44

Fig. 3a: BIHC presentation; BIHC’s activities

52.

Activities at NCGM■

BIHC participates also in the global response to outbreak by sending skilled professionals to help fight against
the threat, as is the case for the Ebola Virus Disease outbreak in the DRC, where Japanese doctors were sent tohelp manage quarantine.
Technical Cooperation
Projects

Afghanistan

Pakistan

India

Nepal

Mongolia

Butan

Egypt

China

Laos

Honduras
Yemen

Bolivia

Viet Nam

SenegalBrazilCambodia

Democratic Republic of the Congo

Indonesia

Zambia11

Bangladesh Myanmar Thailand
Zimbabwe Madagascar

Fig. 3b: Group photo with the BIHC representative

2.3

Fig. 3c: NCGM’s collaboration network

Department of Tropical Medicine and Malaria, Research Institute

The NCGM-Research Institute by its

Characteristics of the malaria diagnostic tests

Department of Tropical Medicine andSensitivity

Malaria has a mission to contribute to
global health by the research on tropical
medicine and malariology.

Timerequired

Various activities in the department
and the international health cooperation

Field
friendlinessnetwork were introduced. The lecturer
touched on different devices used todiagnose asymptomatic malaria and thecollaboration with the Institut Pasteur duLaos and Mahidol University.

Fig. 4a: Department ofFig. 4b: Malaria diagnostic tests available at theTropical Medicine and

NCGM

Malaria presentation

Specifics on research involving DIT’s participation and international health cooperation with Mahidol
University were shared.
During the same session, DIT’s facilitation functions and responsibilities in the previously mentioned research
projects were presented by the regional manager involved.

2.4

Experience from a Clinical trial site: Mahidol University, Faculty of Tropical
Medicine case

Conducting clinical trials needs to fulfill minimum requirements to reach the standard of safety and efficacy.
Each site and/or each study has its peculiarities.
Clinical trial professionals are facing multiple challenges in order to comply with ethical, regulatory, sponsor
and study requirements.
The delegate from Mahidol University shared about the challenges and experiences of their institution.
After a brief introduction on their study site, he shared about his experience as Principal Investigator (PI) in
clinical studies. From the protocol writing to the publication of research results, the role of the PI was actively
commented and discussed among delegates.
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

45

Comment from: Dr. Maria Lawrensia Tampubolon, Sulianti Saroso Infectious Diseases Hospital, Indonesia“The problem of diagnosis and therapy can be a challenge in eradicating the disease. So, the innovation andcollaboration based on each country’s resource become important.”

Fig. 5a: Mahidol University delegate presentation;

Fig. 5b: DIT presentation; Overview of NCGM DIT’s projects in

Responsibility of Principal Investigator

ThailandFramework
DIT•

Research funding•

Investigational products•••

Automated Hematology
Analyzer
Malaria LAMP Kit

Document Reviews (e.g.
Protocol, Procedure)

Study site

SponsorCollaborators

•
•
•
•
•
•
•
•
•
•

MOU

Protocol Development
Document Reviews (e.g.
Protocol, Procedure)
Regulatory and EthicalObligation
Project Management
Site Visits and Study
Monitoring
Quality Management
Data Management
Reporting of Safety Data
Study Budget
Study Cooperation•

Study implementation•

Document Reviews (e.g.
Protocol, Procedure)•

IRB Correspondence•

Reporting of Safety Data•

Analyze the data

© 2018 National Center for Global Health and Medicine

Fig. 5c: Role of the PI slide from Mahidol University

2.5

22

Fig. 5d: NCGM’s Thai projects framework

Disease Control and Prevention Center (DCC)

Activities at the DCC were divided into twoparts; the lecture and the facility visit. Since thiswas during the time of the outbreak of the 2019 newCoronavirus in China, the lecture mainly focused ona brief introduction of the Japanese regulations andframework in response to emerging infectious diseases.
DCC has developed and improved their activities
based on their experiences such as construction of ahigh-level isolation unit, training course for the staff,
response team structure, and standard flow for the
first response. Participants were interested in DCC’sFig. 6a: DCC’s activities

training course and its maintenance program whichemphasizes readiness in terms of infection control. The discussion extended into the management of turnover oftrained staff. During the facility tour, participants visited the high-level isolation unit and observed that it is wellequipped to give the patients intensive care in case of an emergency, as well as comfort during their isolation.
46

2.

Activities at NCGM■

Comment from: Dr. Antonio Villanueva, Department ofInternational Trials, NCGM, the Philippines“Unlike previous years, his discussion was interrupted several
times because COVID-19 had just entered Japan. Just in time forthe trainees to take part in history in the making. To this day, Dr.
Ohmagari continues to lead anti-COVID efforts in Japan and thetrainees were sent home safely.”Fig. 6b: DCC presentation

2.6

Department of Data Science, Center for Clinical Sciences

Quality data is a must for building
evidence to be used in clinical practice.
Referring to a newly published paper,
the lecturer introduced some types ofdata collection with emphasis on thestandardized electronic data capturingsystems. He reminded about one thing
to keep in mind; “Researchers have theirFig. 7a: Data management system

Fig. 7b: Discussion with Data Sciencein the NCGM

Department representative

preferences on each of the systems and data structure, therefore, close communication between researchers anddata scientists is key for a better outcome.”
Comment from: Dr. Weerawat Kiddee, Prince of Songkla University, Thailand“At the end of the lecture, we have realized that to generate and to promote international collaboration, forsure, we need the standard tool to manage the clinical data.”

2.7

National Center Biobank Network (NCBN)

The National Center Biobank Network (NCBN) is a groupof six biobanks located at six national centers in Japan.
The six national biobanks store samples related to theirrespective specialties. While each national center biobank
collects its related sample, there has been developed acommon platform for the management of specimen.
Any researcher who wishes to use biodata can apply tothe secretariat and the acquisition of samples is possible
for anyone who fulfills the requirements.
Lecturers from the NCBN and from NCGM’s biobank

Fig. 8a: NCGM biobank visit
Six National Centers - Six diseases-based biobanks
Alzheimer diseases
Schizophrenia
Epilepsy

use their catalog database. This is a repository of the list of
specimens available in the bank.
The NCGM biobank stores samples (blood, etc.)

NCGM biobank facility could show an overview on how theHIV
hepatitis B

National Cerebral
andCardiovascularCenter (NCVC)

Ischemic heart diseases
Chronic heart failure

obtained from patients with infectious diseases, metabolic
disorders, and immune-related disorders. A site visit at the

National Center for
Global Health andMedicine (NCGM)

National Center of
Neurology and Psychiatry(NCNP)

explained how the biobank works and demonstrated how to

Dementias

Tokyo (東京)

Osaka(⼤阪）

National
CancerCenter (NCC)

Nagoya (名古屋)

CancerNational
Center for
Geriatrics andGerontology(NCGG)

National Centerfor Child HealthandDevelopment
Pregnant women(NCCHD)

New born babies

Fig. 8b: National Center Biobank Network

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition47

biobank stores the samples with strict and close monitoring.
Comment from: Dr. Melva Louisa, University of Indonesia, Indonesia“My opinion is the research using the biobank network can be very promising in the future.”

NCGM (local) Biobank
The Main Mission of NCGM
NCGM has been confronting the challenges in discovering
the pathology of globally-significant communicable andnon-communicable diseases in order to overcome them.
NCGM Biobank is utilized for:l Detection of disease progression factor and development of easy
diagnostic technology for hepatitis.
l Identification of novel target molecules and detection of biomarkers
for complications.
l Development of innovative, novel anti-hepatitis virus agent.
Samples andclinical info

Fig. 8c: NCBN catalog database portal

2.8

Utilization

REC (IRB)

Fig. 8d: NCGM biobank description

Lecture on Pharmacovigilance

After introduction on the essentials of pharmacovigilance (PV), the delegate from the Democratic Republic of theCongo (DRC) shared his experience on conducting pharmacovigilance in their country.
The PV system in DRC is organized as follows: The National PV Commission is responsible for taking regulatory
decisions based on information provided by the National PV Center. It is located at the Ministry of Health (in the
Directorate of Pharmacy and Medicines). The National PV Center is responsible for collecting and analyzing safety
reports from all over the country. It is located at the University of Kinshasa (Department of Clinical Pharmacology). It
is assisted by an Advisory Committee composed of experts from different medical fields. Regional PV Centers collectdata at province level and report to the National PV Center. The lecturer also shared his experience on conducting
the clinical trial during the Ebola Virus Disease outbreak in North Kivu. Lessons learned, challenges, and solutions
applied into a clinical trial involving various countries’ stakeholders, organizations in an unstable conflict zone, andwhere populations have lack of trust in health workers.
Comment from: Dr. Jay Ron O. Padua, San Lazaro Hospital, the Philippines“His knowledge on pharmacovigilance was exceptional. His passion and enthusiasm in his field of work isapparent throughout his lecture.”

PV system in DRC
Located at the MoH

National PV Commission

Regulatory Authority

Located at the
University of Kinshasa

Advisory Committee

National PV Centre

DSUR,
PBRER

Regional
PV Centres
FP
Healh
Facilities

Fig. 9a: DRC delegate presenting the Pharmacovigilancesystem in DRC

48

FP
PHPs

StudiesPopulation

Fig. 9b: Pharmacovigilance system in DRC

PharmCompanies

3.

3.

3.1

Activities outside of NCGM■

Activities outside of NCGM

Pharmaceuticals and Medical Devices Agency (PMDA)

Comprehensive partnership program between PMDA and NCGM allowed delegates to observe “PMDAATC Multi-Regional Clinical Trials (MRCT) seminar 2020” organized by the PMDA Asia Training Center for
Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC). This seminar, focusing on multi-regional
clinical trials, was designed for representatives of Regulatory Authorities, with the objective to contribute toenhancement and mutual understanding of regulations and strengthening of cooperation in Asia and other partsof the world.
They provided lectures on the topics such as points to consider at protocol designing and planning of MRCT,
clinical operation, clinical data evaluation, regulatory review based on results of GCP inspections, and postmarket safety evaluation of approved drugs based on MRCT. Lectures were provided by experts not only fromPMDA but also diverse specialists from academia and industry with detailed information acquired by theircomprehensive and extensive experiences.
This was a good opportunity for delegates to understand how the Regulatory Authority evaluates the clinicaldata on New Drugs with MRCT.
■ Web page on the PMDA-ATC MRCT Seminar: https://www.pmda.go.jp/english/symposia/0160.html
Table 2“PMDA-ATC Multi-Regional Clinical Trial (MRCT) Seminar 2020

Organizer: The Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
Date: January 20-23, 2020
Seminar program(The following information comes from the above PMDA web page and lists only the program activities attended by the participants.)

History of drug evaluation using overseas data in Japan
Scientific insights about ethnic factors<International cooperation and alignment>
Global Platform for Medical Innovation as an Academic Research Organization
Challenges for global cooperation of regulatory agencies<Points to consider when evaluating results>
Statistical consideration for MRCT based on the ICH E17 G/L
PMDA's experiences to review MRCT results<Consideration for MRCT operation>
Practical issues and solutions on MRCT operations (investigator's view point)
Practical issues and solutions on MRCT operations (industry's viewpoint)

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition49

<Regulatory review based on results of GCP inspection>
How to perform GCP inspection -Role of GCP inspection in review process
How to consider GCP inspection results from reviewer's perspective
Applicant's experiences to undergo GCP inspection<Post market safety evaluation of approved drugs based on MRCT >Global standard for Pharmacovigilance
Risk management plan based on MRCT -industry perspective
Risk management based on MRCT -Regulatory Agency Perspective

Fig. 10: Group photo after PMDA lecture

3.2

SHIONOGI & CO., LTD.

In order to have a broad view of the manufacturing process for research and drug development, the training teamtraveled to Osaka to visit SHIONOGI & CO., LTD. This is a Japan-based pharmaceutical company whose mission is
to constantly strive to provide the best possible medicines to protect the health and well-being of people worldwide.
Shionogi's Global Health Access Policy Statement
says its efforts to improve access are focused in thefour following areas: 1. Developing innovative therapies
to address unmet needs, 2. Promoting proper use of
medicines, 3. Improving affordability for patients in
need, and 4. Strengthening healthcare systems.
During the visit, delegates experienced ademonstration on how to synthesize new compounds
using the automated flow chemistry system.
After the visit of the well-equipped facility (offices,laboratories), experts from the company shared theirexperience on challenges during each phase of drug
50

Fig. 11: Shionogi Co.Ltd. visit

3.

Activities outside of NCGM■

development (from early stage of development to the later phases of clinical trials) using examples of some of theirapproved anti-infectious drugs.
Comment from: Dr. Gelza Mae Almario Zabat, St. Luke’s Medical Center, the Philippines“The advances made by Shionogi is definitely impressive.”

3.3

National Cancer Center Japan (NCC)

The National Cancer Center is the top facility in terms of number of cancer clinical trials in Japan. Activities at
the NCC comprised of a facility tour and lectures from clinical trials professionals. After a brief explanation about
the hospital structure and services, the current situation of clinical trials in the NCC and the achievements whichhave been made in terms of drug development were introduced. NCC has been involved in local and international
clinical trials (MRCTs). Concerning the MRCTs, clinical trials professionals have been facing many challenges
such as the cultural and language differences, varying regulatory requirements, and management of funds andtrial drugs received from pharmaceutical companies.
One of the current challenges is the shortage of Clinical Research Coordinators (CRC) compared to the huge
number of studies conducted at the NCC.
In order to overcome the situation, the NCC appoints CRCs by research area. Also, onboarding with continuous
training further supports clinical research.
During the facility tour, participants visited the inpatient ward for phase 1 clinical trials, outpatient treatment
center, Endoscopy center, Invasive Radiotherapy Center, Biobank, and Interventional Radiology Center.
Comment from: Dr. Suvimol Niyomnaitham, Siriraj Hospital, Thailand“They make clinical trial look so routine that is the model that I have to propose to my faculty here in Thailand.”Fig. 12a: NCC presentation -1

Fig. 12b: NCC presentation -2

Fig. 12c: The national cancer - care network

Fig. 12d: Discussion with NCC doctors

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

51

Fig. 12e: Group photo with NCC represantives

3.4

Osaka University Hospital

Osaka University, a Japanese national university, is ranked as one of Japan's most prestigious institutions ofhigher learning. A facility tour at Osaka University Hospital included visit to the Cell Processing Facility and the Phase
1 unit for clinical trials.
Lectures introduced activities related to three main topics:•

Efforts on conducting Multi-Regional Clinical Research•

Academic Clinical Research Center, Osaka University Hospital•

Medical Center for Translational Research, Osaka University Hospital

Discussions were oriented on each country’s health situation, the organization of the Institutional Review Board/
Ethical Committee, and on how to develop a possible future collaboration.
In addition, Osaka University Hospital staff were happy to share in a big achievement done by one of theirsupported investigator-initiated clinical trials: one day before our visit, the first transplantation of Induced Pluripotent

Fig. 13a: Overseas Engagement of Clinical Research to Develop Academic Seeds

52

3.

Activities outside of NCGM■

Stem cells- based (iPS) - heart sheet had been successfully done.
Comment from: Dr. Maria Elizabeth Mercado, University of the Philippines, Manila, the Philippines“Osaka University tour has set the example of what kind of support can facilitate a thriving research environment
in the academia.”

Fig. 13b: Osaka University Hospital Department of Medical

Fig. 13c: Osaka University Hospital presentation -1

Innovation

Fig. 13d: Osaka University

Fig. 13e: Osaka University

Fig. 13f: Group photo in front of the Center of Medical Innovation and

Hospital presentation -2

Hospital presentation -3

Translational Research

3.5

Japan International Cooperation Agency

Japan International Cooperation Agency(JICA) is one of the world’s largest bilateral
aid agencies supporting socioeconomic

Examples of Yen Loandevelopment in over 150 developing countries
and regions.
After presenting an overview of JICA,
the lecturer presented some examples ofIndonesia: SmallScale Irrigation
Management Project

India: Delhi Mass
Rapid Transport System
Project

Tunisia: Integrated
Reforestation Project

China: Sichuan Higher
Education Project

health-related projects supported by JICA.
These include technical cooperation on postmarket control systems for drug and foodsafety, research capacity enhancement, andstrengthening health management.
Discussions focused on how to request

11

Fig. 14a: Example of yen loan by JICA

JICA’s various types of assistance programs. It
explained that JICA’s projects are based on theofficial requests from the recipient government
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

53

submitted through the diplomatic channel. The question on
partnership with the private sector was also brought up by
participants.
Comment from: Dr. Ngo Van Cong, Cho Ray Hospital,
Viet Nam“JICA organization helps a lot of developing countries.
They produce right efficiency.”

Fig. 14b: JICA representative presentation; Introducing
JICA activities

3.6

Association of Clinical Research Professionals, Japan Chapter

The Association of Clinical Research Professionals (ACRP) is a Washington, D.C.-based non-profit organization
with more than 13,000 members in more than 70 countries which supports clinical research professionals throughmembership, training, development, and certification. Activities and certification programs of ACRP, especiallyfor the Certified Principal Investigator (CPI), were introduced. Also, as one of the global chapters, information of
ACRP Japan’s activities including educational programs and site visits abroad were shared at the session, as wellas support for certification exam.
Comment from: Dr. Nsengi Ntamabyaliro, The Institut National de Recherche Biomédicale, DRC“For me, it was good not only to discover that this association exists, but also that there is training materials,
online trainings, webinars, and also certifications for different positions.”
ACRP Global

Organization© Association of Clinical Research Professionals � acrpnet.org

Fig. 15a: ACRP organization

3.7

Fig. 15b: ACRP - Japan members

Science Museum

With the intention of feeling the evolution of new technologies in relation to science in general and particularly
in medicine and drug development, participants visited two museums, named National Museum of Emerging
Science and Innovation: “MIRAIKAN” and Daiichi Sankyo Medicine Museum: “KUSURI MUSEUM”.
Comment from: Dr. Mboloko Mata Junior, University of Kinshasa, DRC“In “Miraikan”, I was impressed by robots; it was so interesting to see how you can make science for better life.”
54

3.

3.7.1

Activities outside of NCGM■

National Museum of Emerging Science and Innovation: “MIRAIKAN”

Miraikan was created with the objective of deepening understanding of science and technology and fulfilling
the Japan's aim of becoming a scientifically and technologically creative nation. Exhibitions include various
discoveries highlighting technological progress, global environment, space exploration and life science.
Participants experienced medical discovery history such as the iPS cells, the importance of Artificial
Intelligence in medical practice, laparoscopic surgery, etc.
■ Miraikan website: https://www.miraikan.jst.go.jp/en/aboutus/

Fig. 16a: Miraikan visit -1

3.7.2

Fig. 16b: Miraikan visit -2

Daiichi Sankyo Medicine Museum: “KUSURI MUSEUM”

Kusuri Museum offers free facility visits in order to develop the proximity of medicine and drug development
process to the general public. Inside the museum, participants could experience while playing the history of drug
development.
■ Kusuri Museum website: https://kusuri-museum.com/intro

Fig. 17a: Kusuri Museum visit -1

Fig. 17b: Kusuri Museum visit -2

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

55

4.

Open presentation session

The open presentation session had been planned to share the Challenges and Suggestions on Drug/Device
Development situation in their respective countries with the registrants from inside and outside of NCGM.
Unfortunately, it was canceled due to the outbreak of COVID-19. Presentations were instead shared withlecturers, participants, and registrants for the event, as well as uploaded to DIT’s homepage.

Department of International Trials
training network conference

Challenges and suggestions on
drug/device development
in ASEAN & African countries

There is a gap in Research and Development (R&D) between different
countries and regions in the world.
Speakers from five countries including Thailand, Indonesia, Vietnam, The
Philippines and the Democratic Republic of the Congo will present aboutclinical trials conduct at their respective countries from their point of view.
Discussions will focus on future collaboration for clinical research andcomparison with system in Japan.
Everyone involved or interested in clinical research is WELCOME!

Date：January 30, 2020
Time : 10:00 – 12:00（Doors Open at 9:30）
Registration

QR codeVenue: NCGM Research Institute Conference Room AB
Fee: Free（Prior registration required）
Registration: HereContact:
NCGM Department of International Trials Ichikawa/Narita
Language: English
Tel/ 03-6228-0445 Email/ dit-info@hosp.ncgm.go.jp

Fig. 18: Open seminar flyer

56

4.

5.

Open presentation session ｜ 5.

Conclusion■

Conclusion

The 2019 NCGM/CCS country-specific MRCT capacity building: “A program focused on comprehensive
and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and Africancountries, 2nd edition", a 14-day training program which brought 13 participants from 5 countries and 1 fromJapan to enrich knowledge on regulatory management of MRCT’s data, the organization of Japanese clinicalresearch/trials settings, Japanese government efforts for global health contribution, and storage of specimen
for future research. In addition, they experienced the real world of research and drug development after learningwhich competencies are needed for clinical research professionals.
Although the open session was canceled, presentation slides were shared among lecturers, registrants andparticipants.

■ Comment from: Osaka University team,Dr. Chisa Tabata:“The most impressive part for me was the very good communication among trainees, lecturers, andNCGM members; I believe we can have a very good collaboration for MRCT in the future.”
Dr. Myoui:“I hope you all enjoyed the program of NCGM.”
Dr. Nakatani:“I hope this program will help you to deepen your experience and knowledge.”

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

57

Future Prospects

Thirteen researchers from five countries and one researcher from Japan were invited to participate in the 14-day
training program held in January 2020, "A program focused on comprehensive and collaborative training on medical
innovations adapted to challenges of clinical trials in Asian and African countries, 2nd edition".
The participants greatly appreciated the lecture on regulatory harmonization given by experts from the PMDA, as
well as other lectures from the clinical setting (NCGM, NCC), academia (Osaka University), JICA, ACRP Japan, privatecompany (SHIONOGI & CO., LTD), together with other opportunities to learn about situations in various countries. At
the same time, however, they suggested that we should include more active training activities such as discussions
with experts based on case studies.
We appreciate the continued guidance and encouragement provided by the relevant organizations andprofessionals.

58							

Tatsuo Iiyama																					

Director, Department of International Trials,
Center for Clinical Sciences,
National Center for Global Health and Medicine

別添 / Appendix

別添 1 / Appendix 1

インターナショナルトライアル部 バナー /Department of International Trials banner

紺/黒の線を後面に
DITロゴなし

2019.12.10
Design FIX

Department ofInternational Trials
Innovation for Global Health
W3000×H600

60

別添 / Appendix

別添 2 / Appendix 2■

スケジュール / Training Program Schedule

The 2020 NCGM/CCS Counry-Specific MRCT Capacity Building
Duration: Jan. 18- Jan.31, 2020
Date
【Day1】

Jan. 18, 2020
【Day 2】

Jan. 19, 2020

【Day 3】Jan. 20, 2020
【Day 4】Jan. 21, 2020

【Day 5】Jan. 22, 2020

【Day 6】

Jan. 23, 2020

【Day 7】Jan. 24, 2020

【Day 8】Jan. 25, 2020
【Day 9】Jan. 26, 2020
【Date 10】Jan. 27, 2020

ProgramArrivalOrientation: Life in Japan, self-introduction, paperwork
Lunch from 7-11 (convenience store) or LIFE (nearby supermarket)
Introducing NCGM(Video) and DIT (lecture)
Ice breaking activities
Lecture: PMDA
Lunch
Lecture: NCGM: DIT: Competency Wheel
Lecture: PMDA
Lecture (plus facility visit): NCC
Lunch
Lecture: PMDA
Lecture: PMDA
Lecture (plus facility visit): NCGM: DCC
Lecture: NCGM: BIHC
Lunch
Preparation for presentation
Lecture: PMDA
Lunch
Lecture: PMDA
Greeting: NCGM President and NCGM Hospital Director
Lecture: JICA
Lecture: DRC delegate: Safety reporting and pharmacovigilance activities in practice
Lunch
Lecture (plus facility visit): National Center Biobank
Lecture: ACRP, Japan Chapter
Kusuri Museum
Lunch
Miraikan museum
Presentation preparation day
Lecture: NCGM: Department of Data Science
Lunch
Lecture: NCGM: Research Institute: Tropical Medicine and Malaria Department
Lecture: NCGM: DIT: Project collaboration with Thailand
Lecture: Thai delegate: Case study of clinical trials from experience in Thailand【Date 11】

Travel to Osaka
Lecture (plus facility visit): Shionogi & CO., LTD.

【Date 12】

Lecture (plus facility visit): Osaka University
Return to Tokyo【Date 13】

Presentation Session
Certificate Ceremony

Jan. 28, 2020
Jan. 29, 2020
Jan. 30, 2020
【Date 14】Jan. 31, 2020

Departure

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition61

別添3 / Appendix 3 公開プレゼンテーションセッション発表資料 / Presentation Handouts
1. Challenge and Suggestions on Drug or Device Developmentin the Democratic Republic of the Congo (DRC)
Mboloko Mata Junior / Nsengi Ntamabyaliro

DRC
CHALLENGES AND SUGGESTIONS ON
DRUG/DEVICE DEVELOPMENT
IN DEMOCRATIC REPUBLIC OF THE CONGO (DRC)
Junior Mboloko, MD MSc
Nsengi Ntamabyaliro, MD, MSc

1

4

CultureOutline

Democratic Republic of Congo(DRC)• More than 400 tribes and 250 languages• Official language (french)• 4 national languages (Lingala, Swahili,
Tshiluba and Kikongo)• Most Congolese speak at least 3
languages: Local tribal language, Local
National Language, French.
• Congolese Music, played all over Africa• DRC overview• Health system• Clinical trials in DRC• Challenges• Strengths and opportunities

2

5

3

6

Democratic Republic of Congo(DRC)• 2nd largest Sub-Saharan Africa
country :2,345,409 km2 (about 6
times Japan)• Population: 95 millions(population growth: 3.3%/year)• Urban (30%), rural (70%)• Accessibility within the country:
flight is the only way to reachsome places from Kinshasa(capital city)• Climate (tropical wet), 2 seasons(rainy and dry); Averagetemperature: 24.6° c (17-31)

62

｜別添 3 / Apendix 3 ｜ 1.

Challenge and Suggestions on Drug or Device Development in the Democratic Republic of the Congo（DRC） ■Health system

Health area

Tuberculosis

Communicable diseases

University Clinics of Kinshasa

University

Situation (Deaths)

Hospital
Provincial
Hospital

Provincial
Division

Health Zone

Health problems
Health system

General secretariat
Centrel Directorates
Health Programs

General Referreal
Hospital (HealthZone
1. Top 10
2. All 3 of WHO’s
high burden
3. Treatment
coverage 57%, lowtreatment successrate, Low detection
rate 48%

Health Centre•Patients pay all healthcare services out of their pocket•No public insurance•Big firms provide healthcare to personnel•Assistance provided by NGOs & donors to fight high-burden diseases•Private sector still growing (in each level), agreements with PHD to be involved in the national policy

Incidence (MDR/RR-TB)
9.7 (4.9–15) per 100000.

Mortality Rate per 100 000 population per year

Source: WHO estimates,
2018
WHO Global TB program
2019

10

7

10

Health problems

Health problems
ü10 most causes of deaths, allages

Two major outbreaks ongoingüTen most causes of deaths < 5

Ebola outbreak: Eastern regions• As of 09 January 2020:• Malaria• Lower respiratory infection• Tuberculosis• Diarrheal diseases• Protein-energy malnutrition• Neonatal preterm birth• Neonatal encephalopathy• HIV/AIDS• Neonatal sepsis• Congenital defects• Malaria• Lower respiratory infection• Tuberculosis• Diarrheal diseases• Cerebrovascular diseases• Ischemic heart diseases• Protein-energy malnutrition• HIV/AIDS• Preterm birth complications• Birth asphyxia and trauma• 3416 cases,• 2240 deaths,• 1142 survivors

Health problems
Admissions and deaths(The worst outbreak, WHO says)
As of 07 Jan 2020
• Over6000 deaths• 310 000 suspected measles cases• 18 million children under 5 vaccinated8

Communicable diseases

Measles outbreak: allover thecountry

11

Health problems
Malaria

Non communicable diseases

Policies and strategies

12% of all malaria cases worldwide just after Nigeria ( 25%),
Reduction in malaria deaths but still slower.
https://www.severemalaria.org/countries/democratic-republic-of-congo
WHO World Malaria Report 2018

9

12

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

63

Research centres and consortia exemples

Health problems

Neglected diseases
Human African
Trypanosomiasis (HAT)

towards elimination:• from 27,000 case in 1996 to• 650 in 2018.

Elimination: 2020.

13

Clinical trials: status and infrastructures
None
Discovery andDevelopment

PreclinicalResearch

INRB (JICA centre)
UNIKIN

Phase
1

Phase
2

Laboratories and research institutions• Institut national de recherche biologique(INRB)• Pronanut: (National program for nutrition)
Institut de recherche sur les sciences de la santé(IRSS)

University of Kinshasa
University of Lubumbashi
University of Goma

Kongo University

PrivateStudy title

Condition

Intervention

Location

SponsorInvestigational Therapeutics for theTreatment of People With Ebola Virus
Disease (multioutbreak, multicentre
RCT)

Ebola

mAb114, REGN-EB3

Beni, Butemb, Katwa, Mangina

NIH

Cohort Event Monitoring Study of
Pyramax®

Malaria

Pyramax

DRC (Kinshasa, Kimpese), Congo,
Gabon, Cameroon, Ivory Coast,
Switzerland (Closeout visit soon

MMV/Shin Poong

Prospective Study on Efficacy and Safetyof SCYX-7158 in Patients Infected by
Human African Trypanosomiasis Due toT.b. Gambiense

Human African
Trypanosomiasis

Acoziborole

Many locations (12) in DR Congo and 1site in Guinea

DNDi

DIAgnostics for Multidrug Resistant
Tuberculosis in Africa

MDR Tuberculosis

Diagnostic Tesst: Deeplex test,
InSilixa chip assay, GeneXpert
Fluorescein DiAcetate (FDA)

INRB, ITM Antwerp, some countries

Laboratoire deRéférence desMycobactéries

University of Bukavu

Research institutions
Universities)

and113 CT registered in theInternational Clinical Trials
Registry Platform (WHO)

Phase
4

Research
institutions(Universities)

Centre national de transfusion sanguine(CNTS)
Centre de recherche en Maladies Tropicales del’Ituri(Public

Clinical trial: examples

73 studies registered in
Clinicaltrials.gov, with 13
phase 2 studies and 2 phase
1studies.

Universities
Sponsor trials centre

Phase
3

16

Catholic University of Graben
University of Kisangani
Others provincials and privates
Universities
14

There is a lack of facilities and equipment for drug development and clinical trials

14

17

Clinical trial: examples

Clinical trials: regulatory matters
Directorate of Pharmacy and Medicine (DPM,
MoH)
Drug approvalcommission• CTD format (ICH), 5 modules• Harmonization procedures with
SADC countries• Quarterly meeting
Pharmacovigilance• Existing guidelines

commission• Half yearly meeting• Guidelines drafted

Advertisingcommission
Guidelines not existing

Clinical trial
commission• Newly created• Guidelines drafted

Study title

Condition

Intervention

Location

Sponsor

Diagnostic Tools for Human African
Trypanosomiasis Elimination and Clinical
Trials: Early Test-of-cure (DiTECT-WP4)

African
Trypanosomiasis

Diagnostic Test: RNA andneopterin detection

Many sites in the
country

Institute of Tropical
Medicine (Belgium)

Arresting Vertical Transmission of
Hepatitis B Virus (AVERT-HBV)

Hepatitis B

Tenofovir Disoproxil
Fumarate, Monovalent
HBV vaccine

Kinshasa

University of North
Carolina

Community Access to Rectal Artesunate
for Malaria (CARAMAL)

Malaria

Rectal artesunate

DR Congo, Nigeria,
UgandaUNITAID, SWISS TPH,
CHAI, UNICEF

Fexinidazole in Human African
Trypanosomiasis Due to T.b. Gambiense at
Any Stage (FEX009)

Human African
Trypanosomiasis

Feninidazole

Many locations in
DR Congo

DNDi

15

15

64

18

｜別添 3 / Apendix 3 ｜ 1.

Challenge and Suggestions on Drug or Device Development in the Democratic Republic of the Congo（DRC） ■Regulations: Regulation
not yet completed:guidelines on Clincal
trial

Challenges

Lack offacilities/equipme
nt dedicated toclinical trials

Type of diseases:
CT in situation ofoutbreaks (Ebola)

Personnel: notenough personnel
trained in
Clinical Trial.

National Infrastructures: Poor
infrastructures in rural and remoteareas (roads, rivers) →logisticalchallenges

Security: easternregions

Language andcultural barriers

19

Swahili Proverb
You cannot know what you can do until you
have tried.
22

Regulations: DRC is member of SADC (Southern
Africa Development Community) whith RHI (regional
harmonisation initiative)
Regulation: drafting of documents, commissions
created, implementation of CTD

Strenghts

Personnel: increasing number of trained personnel inClinical trials

National and international collaboration: Clinical trial
Centre at INRB (Jica); ARCEAU etc

Infrastructures: improving with the increase in clinical
trials and collaboration (capacity building)20

Clinical trials:
opportunities

Variety of diseases (re-emergent, neglected, noncommunicable diseases)
Gene diversity of inhabitants (pharmaco-genetics study)
Co-existing of various patterns of certain diseases(malaria patterns “tropical-equatorial-mountain”)
Cost-effectiveness (rapid inclusion “less time”, reduced
cost)
Existing local CRO (Swiss TPH, DNDi) and ethics
committees
Improvement of Regulatory Authority over time

21
Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition652. Challenge and Suggestions on Drug or Device Development
in Indonesia
Maria Lawrensia Tampubolon / Melva Louisa Simbolon / Dina Nilasari

Leading cause of Disability Adjusted
Life Years (DALYs): 1990 – 2006 - 2016
1990

Challenge and suggestion
on drug or device development
in Indonesia

2006
1.Diarrheal diseases
2.Lower respiratory inf.
3.Tuberculosis
4.Neonatal preterm birth
5.Ischemic heart disease
6.Neonatal encephalopathy
7.Measles
8.Cerebrovascular disease
9.Road injuries
10.Congenital defects

2016
1.Ischemic heart disease
2.Tuberculosis
3.Cerebrovascular disease
4.Lower respiratory inf.
5.Diarrheal diseases
6.Neonatal preterm birth
7.Neonatal encephalopathy
8.Low back and neck pain
9.Road injuries
10.Diabetes

1.Ischemic heart disease
2.Cerebrovascular disease
3.Diabetes
4.Tuberculosis
5.Low back and neck pain
6.Neonatal preterm birth
7.Sense organ diseases
8.Road injuries
9.Skin diseases
10.Diarrheal diseases

Maria Lawrensia Tampubolon (SS-IDH)
Melva Louisa Simbolon (Faculty of Medicine University of Indonesia)
Dina Nilasari (Mochtar Riady Institute)1

4

Top 10 Cause of Death and Disability in Indonesia

INDONESIA :About 17.000 islands,
rainy and dry season, 714
ethnichttps://www.who.int/countries/idn/en/

2

Risk factors for deaths and disability combined

Indonesia

https://www.who.int/countries/idn/en/

https://www.who.int/countries/idn/en/

3

66

5

6

｜別添 3 / Apendix 3 ｜ 2.

Challenge and Suggestions on Drug or Device Development in Indonesia ■Number of New Cases and Deaths Due to HIVAIDS in RSPI-SS in 1995-2018

Unmet Needs in Drug Development in Indonesia

until Feb 2018

• The rise of NCD → Management of risk factors and treatment for CVD• Tuberculosis, neonatal preterm birth complications, diarrheal, and lower
respiratory tract infections are still substantial contributors to DALYs• Neglected tropical diseases: filariasis, leprosy• Rare diseases• Drug resistant organisms (MDR TB, Drug resistant malaria)

700

250

640
595

593

600

203
526

500

200

438
394

147

400

150
324

114

300

100

200

238

72

163

3

0

0

0

0

2

0

4

35

10
0

0

32
10

64
4

17

8

New cases
Kasus
baru

259

100

50

38

22
4

Mboi N. On the road to universal health care in Indonesia. Lancet 2018; 392: 581–91
Maharani A, Tampubolon G. Unmet Needs for Cardiovascular Care in Indonesia. PLOS ONE; 2014: 9(8): e105831.
Riskesdas 2018.

288

158 163

51
100

307

260

13

61

31

13

12

8

2 0

Meninggal
Dead

7

10

Opportunistic infection in HIV-AIDS pts

10 Most Infectious Disease cases
at Outpatient unit in SS-IDH in 2016 - 2018
2016

2017

•HIV
•Tuberculosis•Acute respiratory Infection•Ear diseases & Prosesus
Mastoid•Pneumonia•Diarrhea•Gastritis•Urinary Tract Infection•Pharyngitis•Dengue Hemorrhagic Fever
(DHF)

•HIV
•Tuberculosis•Acute Respiratory Infection•Ear diseases & Prosesus
Mastoid•Diarrhea•Bronkitis, Emfisema & Others
Obstructive Pulmonary
Diseases•Pneumonia•Urinary Tract Infection•Pharyngitis•Dermatitis

350

2018
•HIV
•Tuberculosis•Other Primary arthrosis•Acute Respiratory Infection•Chronic Obstructive
Pulmonary Disease•Diarrhea•Pneumonia•Otitis Media•Urinary Tract Infection•Pulpitis

300

TB

250

Kandidiasis
Candidiasis
Pneumonia

200

Hep C

150

Toksoplasmosis
Toxoplasmosis

100

Diarrhea
Diare

50

Kriptokokosis
Cryptococcus

0

Etiology

Neurologicalcomplication in
HIV 2016-2019

n

Percentage (%)

51

83,6

▪

Toxoplasma▪

Tuberculosis
Meningitis
M. Tuberkulosis

4

6,6

N/A

6

9,8

▪

8

11

Number of Diphtheria Cases by Genderin Inpatient Installation, Year 2015-2018

10 Most Infectious Disease cases at Inpatient unit in
SS-IDH in 2016 – 2018
2017

2018

• HIV
• Dispepsia• Tuberculosis• Diarrhea• Pneumonia• Acute Respiratory Infection• Urinary Tract Infection• Typhoid Fever• Dengue Hemorrhagic Fever(DHF)• Sepsis• HIV• Diarrhea• Chronic Obstructive
Pulmonary Disease• Tuberculosis• Acute respiratory Infection• Typhoid Fever• Dyphteria• Dengue Hemorrhagic Fever(DHF)• Pneumonia• Urinary Tract Infection

350
300

Total

250

150
100

0

211

298

260

200

50

Trends of Diphtheria Case in Inpatient Installation,
Year 2015-2018

250

23

9 7 1637138122150148

14

2015

2016

2017

2018

Laki-laki
male

9

23

138

150

Perempuan
female
Total

7

14

122

148

16

37

260

298

200

Number of Diphtheria Cases by Age Groupin Inpatient Installation, Year 2015-2018

150
100

0
-50

0 1 2 5 2 0 1 00 3 1 1 4 3 2 1 2 2 2

2015

8

2016

1 2 5 564 3 1 3 3 3 4

2017

9 7 6

298

300

60
46
39

50

260

250

28
1715 14 15 1920 14
11

2018

0

16

0

2015

16

31

6

2016
Anak
(≤ 18
Children≤18thn)
yo

9

111

86

100
50

187

174

200
150

Jan
Mar
Mei
Jul
Sept
Nov
Jan
Mar
Mei
Jul
Sept
Nov
Jan
Mar
Mei
Jul
Sept
Nov
Jan
Mar
Mei
Jul
Sept
Nov

2016

• HIV
• Dengue Hemorrhagic Fever(DHF)• Tuberculosis• Diarrhea• Gastritis• Pneumonia• Sepsis• Typhoid Fever• Acute Respiratory Infection• Urinary Tract Infection

DIPHTHERIASURVEILLANCE

37

2017
Dewasa> 18
Adults (≥18
yothn)

2018
Total

12

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

67

Pool of Clinical Investigators andPatients

Clinical Trials in Indonesia

National Center for Infectious Diseases

National Cancer Center

Government

University

National Cardiovascular Center

National Centers

Hospitals

Early Phase 1 and Phase 1

Phase 2National Brain Center
National Respiratory Center
National Mother and Child Health Center

Phase 3

PrivateAcademia

Research Centers
Source: http://clinicaltrials.gov
Assessed: 24th January 202013

Advantages and challenges for CT in
Indonesia
Advantages• Large patient population• Wide variety of diseases• Lower trial cost per patient• Availability of research subjects• Many tropical diseases that can not
be explored in non-tropical countries• Regulatory bodies: in compliancewith ICH-GCP

16• Wide-range of clinical specialists

Faculty of Medicine,
Universitas Indonesia

Challenges• Main hospital:
RSCM: Internationally Accredited (JCI
certified), RSUl
• Networking Hospitals: AHS• Lack of insurance companies thatcovers clinical trial patients• Material Transfer Agreement (MTA)

Staff• In partnership with regulatory bodies (BPOM /Indonesian FDA)• GCP Courses: 3 – 6 times per year
(2019: 220 GCP certified staff)

Hospital
network(AHS)

Recognized by
The Forum for
Ethical Review
Committees in
the AsianandCorrective
Action Plans&
Western
Pacific
Time(submitted)
Region(FERCAP)

EC/IRB• Variable research capability ofinvestigators to conduct CT•

DIARC: Diagnostic & Research Center(Integrated Laboratory; ISO 17025)•

Institute of Human Virus andCancer Biology (BSL-3 equipped)•

14

Research and
Education Center –IMERI:
Indonesian Medical
Education andResearch InstituteIntegrated Lab

Re-Recognition FERCAP
Certificate
2019

SIDCER FERCAP 5-7 September 2019

ARO•

Support in trial management: Clinical
trial supporting unit (CRSU)

17

Regulatory and EC timelines(Sequential)
Drug CTs

EC approval

Indonesian
FDA (BPOM)
submission

Submission
approval andImport license

4-8 weeks
4-8 weeks
4 weeks
Medical DeviceCTs

EC approval

Ministry of
HealthSubmission
approval andImport license

Ali S et al. Challenges of conducting clinical trials in Asia. Int J Clin Trials. 2018 Nov;5(4):194-199

15

68

Member of AAHCI (Association of
Academic Health Center International)18

｜別添 3 / Apendix 3 ｜ 2.

Challenge and Suggestions on Drug or Device Development in Indonesia ■IMERI MILESTONES

2016

2021

Other Clinical Studies
2026

ESTABLISHMENT ORGANIZATION

Indonesian
MedicalScienceTechno-Park

ClinicalresearchResearch focus
Drug development: NCD and IDs

Safety and efficacy Starfer(R) towards sperm
parameters in patients with idiopathic oligoasthenoteratozoospermia:
A multicenter, randomized, double-blind, andplacebo-controlled study.

Vaccine development
Contraceptive method development

Medical technology (medical instrumentation, tele-medicine, IT)

On
going
studiesDiagnostic
Research

Efficacy and safety study of Tafenoquine co-administeredwith Dihydroartemisinin-piperaquine (DHA-PQP) for theradical cure of Plasmodium vivax (P. vivax) malaria.
NCT02802501.
Sponsor: GSK / MMV

Indonesian human genetic research centerIndonesian human reproduction and family planning research center

Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in
Type 2 Diabetes Mellitus Patients.
NCT03352674. Tarigan TJE, et al.
Sponsor: PT Kalbe Farma, Indonesia

Indonesian stem cell research centerIndonesian medical education research and development center

A Multi-country, multi-center, observational, retrospective
study to reveal the patient characteristics, disease burden,
treatment patterns and patient journey of stage III non-smallcell lung cancer patients (KINDLE)

Indonesian clinical research supporting unit

19

22

FMUI’s current international
collaboration

Sulianti Saroso Infectious Disease
Hospital (SS-IDH)
Location Map
JL. BARU SUNTERPERMAI RAYANORTH JAKARTA
14340
Indonesia

129 withJapan(based on number of publications indexed in Scopus)

20

Clinical Trials
Early phase

Phase 2

Hospital profile❑ Technical Unit of the Ministry of Health, Republic of Indonesia.

Post Marketing
Surveillance

Phase 323

❑ Specific Hospital for Infectious Diseases, Type A hospital with National
Accreditation (SNARS ED.1)❑ Teaching Hospital (AHS – UI)❑ 156 beds

Otsuka Japan❑ Primary health care network

Otsuka JapanR uang Isolasi

21

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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

69

Clinic monitoring for clinicalresearch/clinical trial

Ward

25

28

Biobank facilities in Sulianti Saroso
hospital disease

HIV clinic

Freezer

Fridge-80C,
2 unit-20C,
1 unitRefrigerator 4C,
1 unit26

TB-MDR CLINIC

29

SS-IDH Institutional collaboration• NCGM• National Institute Health and Research Development - Ministry of
Health Republic of Indonesia• INA RESPOND : multicenter clinical research network in Indonesia• Academic health system – University of Indonesia (AHS –UI)• Eijkman institute• Bandung technology Institute• Primary health care network in North Jakarta

27

70

30

｜別添 3 / Apendix 3 ｜ 2.

Challenge and Suggestions on Drug or Device Development in Indonesia ■Collaboration opportunities

SS-IDH On going Research Activities• Proactive study (HIV)• TB study• AMR study• Diptheria study• NeuroAIDS study• Biobank study (suspect MersCov study has been published)

Infectious Diseases (IDs)

Non Communicable Diseases (NCDs)• TB• HIV incl. opportunistic infection• Emerging and re-emerging infectious
diseases (ERID)• Vaccine (avian flu; “halal product” issue)• Evaluate failed therapy for infectious
disease (HIV TB, diphtheria, etc.)• Research that utilizes Biobank (note:research on biobank negative suspects ofMers have been published)• Drug Resistance in Malaria• Tobacco related diseases• Treatment and Risk Factor Management of
NCDs (Metabolic syndrome)• Stunting• Pregnant women morbidity

31

MRIN

34

Suggestions• Clinical research/clinical trial proposal should be made together• Affordable and low technology medical/health devices• Capacity building for how to build a good system for clinicalresearch/ clinical trial

MedicalScienceGroup

MRIN Ethic Committee (Recognized by FERCAP)

32

35

Hospitals profiles

Thank You

33

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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

71

Research and Education Center – IMERI:
Indonesian Medical Education and Research Institute

Ethics Committee: Recognized by FERCAP
Previous Recognition:
2012
2016

Corrective
Action Plans &Time(submitted)

Re-Recognition FERCAP
Certificate
2019

Lantai 12

Executive meeting room

Lantai 11

Center of medical education

Lantai 10

Knowledge center

Human nutrition

Lantai 9

Skill lab

Neuroscience dan brain development

Lantai 8

Skill lab

Stem cell dan tissue engineering

Lantai 7

Discussion room

Molecular dan proteomics lab

Lantai 6

Integrated teaching theatreSL
Lantai 5

Infeksi dan imunologi
CRSU

Drug development, Occupational HealthSport dan exercise
SKY LOBBY

Center of e-learning

Human reproduction, Cardiovascular
Auditorium

Lantai 3
Lantai 2

OfficeLantai 1

Main hall

Human genetic dan Human cancer
Animal research lab
Museum Kedokteran dan Commercial Tennant

Lobby

SIDCER FERCAP 5-7 September 2019

37

40

DIARC: Diagnostic & Research Center(Integrated Laboratory)

RSCM – Cipto Mangunkusumo General Hospital••••

National Referral Hospital,
Under Ministry of HealthInternationally Accredited
FMUI’s main teaching hospital
KENCANAPrivate Ward

Implemented ISO 17025
Molecular Biology Unit

Protein and Immunology
Unit

Cell Culture Unit

Imaging &Electrophysiology Unit

PCR
RT-PCR
Sequencer (Mi-Seq)
Microarray

Immulite
VIDAS
Multiscan ELISA Reader
Flowcytometry
Luminex

Culture room
Biosafety Cabinet
MACS

Patch-Clamp Instrument
Confocal microscope
Dissecting Microscope

KidneyTransplant

KIARAKIRANAOphtalmologic Ward Mother & Child Ward

Liver
Transplant

HIV
Unit

Cardiology
Ward

Stem Cell
Unit

Radiotherapy

Cochlea
Implant

38

41

RSUI:
Universitas Indonesia Hospital

Institute of Human Virus and Cancer Biology
Equipped with BSL-3 facility• 1st clinical trial that will be
conducted:

Topics of Research:• HIV, CMV, Dengue --> mainlyon the study of pathogenesis& vaccine development• Cervical Cancer

Public Service- Plasma Cluster Air Conditioner
testing (Sharp)- NanoEx Ion activity testing(Panasonic)- GLP, ISO, Biosafety Consult• Teaching hospital• Official opening: 13 Feb 2019
• Neuro-cardiovascular diseases, geriatrics,
mother-child health, dental health

39

72• Dose-ranging study of drug XXX• Phase 2• A randomized, double-blind, placebocontrolled for obesity• Planned FPFV: end Jan 2020
• Sponsor: Malaysian Pharmaceutical
Company42

｜別添 3 / Apendix 3 ｜ 2.

Applicant(Government orPre-marketing or
private institutions;Post-marketing
IVD company; CRO)IRB
Approval

Submitapplication to
Directory General

Challenge and Suggestions on Drug or Device Development in Indonesia ■Clinical Trials for
IVD

Processing time: 20 working days

Required Documents:- CT protocol- Informed Consent- IRB approval- Product information- Certificate of Analysis (CoA)- Certificate of Good Manufacturing Product (GMP)- Summary batch protocol (3 consecutive batches)- PI Certificate of GCP- CV of PI- For collaborative CT, contract of collaboration must be included- When laboratory testing is required, certification of laboratory must be included

43

43

Leading causes of
DALY for Indonesia:
1990, 2006, 2016 Clinical trial
opportunities

Mboi N. On the road to universal health care in Indonesia. Lancet 2018; 392: 581–91

44

Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition733. Challenge and Suggestions on Drug or Device Developmentin the Philippines
Maria Elizabeth Mercado / Jay Ron O. Padua / Gelza Mae Almario Zabat

SAN LAZAROHOSPITAL

Philippine Delegates
University of the Philippines, National Institutes of Health (UP-NIH)

MARIA ELIZABETH P. MERCADO, MD, MAS- Clinical Research•

Project Staff for Executive Director of UP Manila National Institutes of Health; Teaching Assistant to John S. Witte
PhD in Molecular and Genetic Epidemiology
Masters in Clinical Research University of California, San Francisco Department of Epidemiology and Biostatistics.
Certifications: Advanced GCP (UP Manila DCE), Human Subjects Protection Training Stage 1 (CITI Program)
Member, Asian Association for the Study of Diabetes (AASD)•••

San Lazaro Hospital (SLH)

JAY RON O. PADUA, MD, FPPS, FPIDSP- Pediatric Infectious Disease Specialist•• Medical Specialist III, San Lazaro Hospital• Fellow, Philippine Pediatric Society and the Pediatric Infectious Disease Society of the Philippines• Life member, Asian Society for Pediatric infectious Diseases
Visitor Observership and Clinical Preceptorship, Baylor College of Medicine, Texas Children’s Hospital• Participant, The 18th Nagasaki International Course on Research Ethics, Nagasaki University

St. Luke’s Medical Center (SLMC)GELZA MAE A. ZABAT, MD, FPCP, FPSMID- Internal Medicine- Infectious Disease Specialist•••

Member, SLMC Institutional Ethics Review Committee; Head, HIV/AIDS Treatment Hub, SLMC-QC
Member, Infectious Disease Society of America
Recent trainings: The Role of Diagnostics in the Antimicrobial Resistance Response, London School of Hygiene& Tropical Medicine; The 18th Nagasaki International Course on Research Ethics, Nagasaki University;
Comprehensive Tuberculosis Course, Curry International Tuberculosis Center, UCSF
1

© 2018 National Center for Global Health and Medicine• Founded 1577
• 500-bed capacity• National referral facility for Infectious and Tropical Diseases• One of the retained special tertiary hospital of the Department of Health(DOH), subsidized by the national government• National Reference Laboratory for Tests on HIV/AIDS, Hepatitis and STIs
• Treatment Hub for HIV/AIDS, TB-DOTS, MDR-TB• Animal Bite and Treatment Center, including snake bite management• With an in-hospital mini-laboratory run by Nagasaki University• Has a Research Ethics and Review Unit, Level III accredited by PHREB• Has residency training program on Family Medicine and Fellowshiptraining program in Adult Infectious Diseases• Clinical rotation for medical clerks from 9 medical schools as well as
students from Nagasaki, Oita, Kansai, Kobe, Tohoku, and Tottori
universities© 2018 National Center for Global Health and Medicine

14National Institutes of Health
University of the Philippines Manila• an institutional home of a network ofvarious research and extension units
specializing in health and socio-biomedical
concerns.
• Strengths of the Institutes• Recognition as Center of
Excellence/Influence/Policy• Multidisciplinary nature and approach• Community-based/oriented programs• Research management available• Committee on research
implementation anddevelopment/Ethics boards
Industry
Funded• Recognition for outstanding
researches
91© 2018 National Center for Global Health and Medicine

Challenges and Suggestions on
Drug/Device Developmentin the PHILIPPINES

Registered Clinical Trials
Local
International
Collaborations
Collaborations

Academia

5

21

12

http://nih.upm.edu.ph/about-nih/organization

2• Internationally recognized private
academic medical center

Ongoing clinical trials

103

Phase I

3

Phase I/II

1

Phase II

6

Phase II/III

2

Phase IIB

1Phase III70

Phase IIIB

1

Phase IV

2

PMS

1

Others16© 2018 National Center for Global Health and Medicine• Accredited by Joint Commission
International (JCI) as an academic medical
center hospital• Trust, Effective Medicine, and Optimized
Services (TEMOS)- accredited forexcellence in medical tourism and quality
in international patient care

PHILIPPINES• Land area: 300,000 km2• 7,107 islands• Three major islands: Luzon, Visayas,
Mindanao• 13th most populous country in the world and7th in Asia
• Population: 104.0 million (as of 2017)• Population density: 342 persons/km2
expectancy of 69.1 years (from 62.2 years in• Life1980)• Research and Biotechnology Group(R&B)• offers a Master of Science Program in
Molecular Medicine• Center for Clinical Trials (CCT)• Level 3 Institutional Ethics Review
Committee (IERC), recognized by SiDCER
and FERCAP• Biobank for Cancer• Center for Human Research Protection
and Office of Research Integrity• improvements in living conditions, better
access to health services, and improved
management and treatment of infectious
diseases(Padilla & Cutiongco-de la Paz, 2016; Dayrit et. al, 2018)www.stlukes.com.ph

3

74

5

© 2018 National Center for Global Health and Medicine

6

｜別添 3 / Apendix 3 ｜ 3.

Challenge and Suggestions on Drug or Device Development in the Philippines ■2019 is a challenging year for the Health Sector
Dengue outbreak – August• 350, 000 cases• More than 1, 300
related deaths

Polio Outbreak –September• 19 years after being
declared “Polio-Free”• 16 cases cVDPs

Measles outbreak –February•(Dayrit et. al, 2018)7© 2018 National Center for Global Health and Medicine

7•42, 000 cases
560 deaths© 2018 National Center for Global Health and Medicine

10

Current Health Situation

Triple Burden of Disease

Physical Infrastructure• 1,224 hospitals• 2,587 city/rural health units• 20,216 barangay health stations(Dayrit et. al, 2018)© 2018 National Center for Global Health and Medicine(Cabral, 2016; Department of Health, 2019)8

8• Current health burden is summarized and addressed by thePhilippine Health Agenda made by the Department of
Health (DOH)© 2018 National Center for Global Health and Medicine

11© 2018 National Center for Global Health and Medicine

12

Leading Causes of Death in Philippines, 2017

Philippine Statistics Authority, June 10, 2019
© 2018 National Center for Global Health and Medicine

9Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

75

National Unified HealthResearch Agenda (NUHRA)National UnifiedHealth Research
Agenda 2017-2022• outlines the areas and topics that needs to beaddressed in the Philippines for the next five
years.
• Put together by the Philippine National HealthResearch Systems (PNHRS)• Core agencies:• Department of Health (DOH)• Philippine Council for Health Research andDevelopment (PCHRD)• Commission on Higher Education (CHED)• University of the Philippines Manila –National Institutes of Health (UPM – NIH)
(Lopez et al., 2019; PNHRS)© 2018 National Center for Global Health and Medicine

13© 2018 National Center for Global Health and Medicine

https://clinicaltrials.gov/ct2/results?cntry=PH&Search=Clear&age_v=&gndr=&type=&rslt=

17

16International Trials in the Philippines as ofJanuary 2020 from ClinicalTrials.gov

Research
outputs andfinancing

Study Phase

Completed

Ongoing

Early Phase 1

1

0

1

Phase 115

217

Phase 2

111

27

138

Phase 3

401

96

497

Phase 484

690

Others

73

32

105

685

163

848

Total

Total

https://clinicaltrials.gov/ct2/results?cntry=PH&Search=Clear&age_v=&gndr=&type=&rslt=© 2018 National Center for Global Health and Medicine(Lopez et al., 2019; PNHRS)

14

17

18

© 2018 National Center for Global Health and Medicine

RESEARCH
PRIORITIES© 2018 National Center for Global Health and Medicine

1576

http://www.registry.healthresearch.ph/index.php/registry?view=reports&layout=yearly(Lopez et al., 2019; PNHRS)© 2018 National Center for Global Health and Medicine

1918

｜別添 3 / Apendix 3 ｜ 3.

Challenge and Suggestions on Drug or Device Development in the Philippines ■Ongoing Collaborative Researcheswith Japan-based Institutions (N = 31)
Dokkyo Medical University
Eisai Co., Ltd.
Hi-Eisai Pharmaceutical, Inc
Kyushu University, Faculty ofAgriculture
Kyushu University, MishimaKaiun Foundation
Nagasaki University, Institutesof Tropical Medicine
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical
Development andCommercialization, Inc.
Philippine Nikkei Jin Kai
Polyclinic and Diagnostic
Center, Inc.

1
2
1
1
1
1
1
2
4

Santen Pharmaceutical Co., Ltd.
Santen Philippines Inc.
Shionogi
Shire
Shire Human Genetic
Therapies, Inc
Takeda Development Center
Asia, Pte. Ltd.
Takeda Global Research andDevelopment Center
Takeda Pharmaceutical(Philippines), Inc.
Takeda Vaccines, Inc.
Takeda Vaccines, Pte. Ltd
Tohoku University
Tokyo Metropolitan University

1
1
1
2

LACK OF TREATMENT OPTIONS &INACCESSIBLE DIAGNOSTIC
DEVICES1• Conduct morequality researches• Increase submissionof researches for
publication• Participate in multiregional/ global
clinical trials

3
1
1
1
3
1
1

http://www.registry.healthresearch.ph/index.php/registry?view=reports&layout=institution© 2018 National Center for Global Health and Medicine

RESEARCH

FINANCIAL CONSTRAINTSCOLLABORATIONS• Promote local
and international
collaborations• Strengthen
public-private
partnerships• Technology
transfer

LACK OF SKILLEDPERSONNEL

CAPACITYBUILDING• Local andinternational
attendance intraining workshops• Online courses• Hands-on skills
building• Observership andmentoring© 2018 National Center for Global Health and Medicine

PAUCITY IN
TRANSLATIONALRESEARCHSERVICE DELIVERY• Develop evidencebased clinicalpractice guidelines(CPGs)• Centralized
repository of
research• Digitalization• Harmonize CPGs andtranslate to policies
to improve health23
delivery systems

19

22

20

PERSPECTIVESThe Philippines has high interest in research, given
the drive of Filipino researches to participate inclinical trials. However, the country, has limited
resources in conducting large scale clinical trials–
being an archipelago, language barriers, financial
constraint, etc). Japan, with its breakthroughs intechnology can definitely help bridge gaps in thePhilippine research initiative
The expertise of Japan on clinical trials, advanced
diagnostic and treatment modalities can facilitate inbuilding the capacity of Filipino researchers andclinicians in coping with both infectious and noncommunicable diseases.
(Iii et al., 2019)20

21© 2018 National Center for Global Health and Medicine

24© 2018 National Center for Global Health and Medicine

23

PERSPECTIVESLACK OF TREATMENTOPTIONS &INACCESSIBLE
DIAGNOSTIC DEVICES• HIV/AIDS; MDRO;
neglected diseases• Minimally invasive orinterventional
treatment modalities• Disease prevention• Targeted treatment• Screening andconfirmatory devices
with fast TAT• Molecular assays

FINANCIALCONSTRAINTS• developmentfrom natural
products• Development ofpoint-of-carediagnostic tools• Clinical researches
and clinical trials© 2018 National Center for Global Health and Medicine

LACK OF SKILLEDPERSONNEL• Research protocol
writing andpublication• grant writing• Health
surveillance andreporting• Monitoring andevaluation

PAUCITY IN
TRANSLATIONALRESEARCH• Communicationand information
dissemination• Clinical practiceguidelines
development• Health policy
development andevaluation

21

22

The collaboration between the Philippines and Japan has
always been present. We hope to strengthen these
towards the fulfillment of UHC in the Philippines.
Financial support, digitalization, technology andknowledge transfer including disaster preparedness andresponse to disease outbreaks and climate change.
Clinical researches on preventive medicine, infectious
diseases and NCDs, newer treatment and diagnostic
modalities- gearing more to targeted and personalized
medicine are great avenues for research collaboration.
Translational and operational researches can also help
improve the current health system in the Philippines.

© 2018 National Center for Global Health and Medicine

25

24Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition77References:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Cabral, E. I. (2016). The Philippine Health Agenda for 2016 to 2022. Philippine Journal of Internal Medicine, 54(2), 11.
de Leon, P. E. N., Sales, R. K. P., Geroy, L. S. A., & Lopez, J. C. F. (2019). Strengthening Science and Technology for Health Research: Perspectives from Trade,
Development, and Innovation. Acta Medica Philippina, 53(3), 238–246.
Department of Health. (2019). Philippine Health Agenda 2016—2022. https://www.doh.gov.ph/sites/default/files/basicpage/Philippine%20Health%20Agenda_Dec1_1.pdf
Department of Health, Epidemiology Bureau. (2015a). Field Health Service Information System—Annual Report, 2015 [Annual Report]. Department of Health.
http://www.doh.gov.ph/sites/default/files/publications/2015_FHSIS_0.pdf
Department of Science and Technology - Food and Nutrition Research Institute (DOST-FNRI). (2016). Philippine Nutrition Facts and Figures 2015: Clinical and Health
Survey. Department of Science and Technology. http://enutrition.fnri.dost.gov.ph/site/uploads/2015_CLINICAL_AND_HEALTH_SURVEY.pdf
Dorotan, M. M. C., Estanislao, R. D. F., Sales, R. K. P., Magdaraog, M. A. C., & Geroy, L. S. A. (2019). Operationalizing the Development of the National Unified HealthResearch Agenda 2017-2022. Acta Medica Philippina, 53(3), 5.
Food and Nutrition Research Institute-Department of Science and Technology (FNRI-DOST). (2015b). 2nd National Nutrition Summit: 8th National Nutrition Survey—“Juan Mission for a Well-Nourished Nation.” http://122.53.86.125/NNS/8thNNS.pdf
Generale, A. J. A., Sales, R. K. P., Dizon, T. S., & Feranil, A. B. (2019). Approaches to Health Research Priority Setting in the Philippines across the Years. Acta Medica
Philippina, 53(3), 4.
Iii, M. U. M., Magdaraog, M. A. C., Magtubo, K. M. P., & Geroy, L. S. A. (2019). Enabling Greater Private Sector Participation in Health Research in the Philippines. Acta
Medica Philippina, 53(3), 7.
Lopez, J. C. F., de Veyra, C. M., Geroy, L. S. A., Sales, R. K. P., & Dizon, T. S. (2019). Envisioning the Health Research System in the Philippines by 2040: A Perspective
Inspired By AmBisyon Natin 2040. Acta Medica Philippina, 53(3), 8.
Lopez, J. C. F., & Dizon, T. S. (2019). Achieving a Responsive Philippine Health Research Agenda: An Analysis of Research Outputs and Underlying Factors. Acta Medica
Philippina, 53(3), 7.
Lopez, J. C. F., Sales, R. K. P., Reyes, K. A. V., & Ho, B. L. C. (2019). Strengthening the Policy Environment for Health Research in the Philippines: Insights from a
Preliminary Analysis of Existing Policies. Acta Medica Philippina, 53(3), 7.
Ongkeko, A. M., Fernandez, R. G., Sylim, P. G., Amoranto, A. J. P., Ronquillo-Sy, M.-I., Santos, A. D. F., Fabia, J. G., & Fernandez-Marcelo, P. H. (2016). Community Health
Information and Tracking System (CHITS): Lessons from Eight Years Implementation of a Pioneer Electronic Medical Record System in the Philippines. Acta Medica
Philippina, 50(4), 16.
Otayza, M. L. K., de Veyra, C. M., & Lopez, J. C. F. (2019). Implementing Lessons Learned from Past Versions of the Philippine National Unified Health Research Agenda.
Acta Medica Philippina, 53(3), 9.
Padilla, C. D., & Cutiongco-de la Paz, E. M. (2016). Genetics and genomic medicine in the Philippines. Molecular Genetics & Genomic Medicine, 4(5), 494–503.
https://doi.org/10.1002/mgg3.247
Santiago, M. L. C. (n.d.). Philippine FDA: Clinical Trial Regulation Guidelines.
Tolabing, M. C. C., & Palatino, M. C. (2018). Assessment of the Research Capacity of the Centers for Health Development, Philippine Department of Health. Acta Medica
Philippina, 52(2), 7.

© 2018 National Center for Global Health and Medicine

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26

SALAMAT! THANK YOU! ARIGATO! MERCI! KHOB KUN! CAM
ON! TERIMA KASIH! ASANTE!
University of the Philippines, National Institutes of Health

DR. LIZ
Phone: +63 919 001 5407
e-mail: Elizabethmercado21@gmail.com
FB: /elizabeth.mercado.3939
San Lazaro Hospital

DR. JAY
Phone: +63 915 434 5727
e-mail: jayronp@yahoo.com
St. Luke’s Medical Center

DR. GELZA
Phone: +63 917 899 0639
e-mail: gelza_mae@yahoo.com
Twitter: @gelza© 2018 National Center for Global Health and Medicine

78

27

26

｜別添 3 / Apendix 3 ｜ 4.

Challenge and Suggestions on Drug or Device Development in Thailand ■4. Challenge and Suggestions on Drug or Device Developmentin Thailand
Suvimol Niyomnaitham / Noppadon Tangpukdee / Weerawat Kiddee

Thailand

Geographically

Challenges andsuggestions on drug/device
development in Thailand-

1

4© 2018 National Center for Global Health and Medicine

422© 2018 National Center for Global Health and Medicine

53© 2018 National Center for Global Health and Medicine

6

Content
v Where are we :Thailand
v Health burden in Thailand(Our personal opinions)v Current situation of research and development
on communicable and non-communicable diseases
v Summarization of unmet needsv Proposed solutions to fill the gaps
v Perspectives [drug and device development perspective]© 2018 National Center for Global Health and Medicine

Thailand© 2018 National Center for Global Health and Medicine

5

Geographically3

6Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition79

Health care coverage for Thais© 2018 National Center for Global Health and Medicine

Credit:https://theitravelchannel.tv

7
7© 2018 National Center for Global Health and Medicine

https://www.nationthailand.com/national/30346131

10
10Thailand health burden
Non-communicable disease > communicable disease

Leading cause of death1) Cancer
2) Road traffic accident
3) Cardiovascular disease
Phase I clinical trial facilities
https://sicres.org

8© 2018 National Center for Global Health and Medicine

8

Health care benefits for Thais

11© 2018 National Center for Global Health and Medicine

11

Thailand health burden (Cont.)
Non-communicable disease > communicable disease

The Ministry of Health has identified that cancer is thenumber one killer of Thai citizens since 1998, adding that outof 122,757 new cases diagnosed in 2019,73,000 patients have died© 2018 National Center for Global Health and Medicine

80

9https://www.nationthailand.com/national/30346131
9© 2018 National Center for Global Health and Medicine

Source: https://thethaiger.com

12
12

｜別添 3 / Apendix 3 ｜ 4.

Challenge and Suggestions on Drug or Device Development in Thailand ■Thailand health burden (Cont.)

Current situation of research and development
on communicable diseases

2.1 Non-communicable disease > communicable disease
Road accident rate worldwide 2019

Emerging problem: respiratory
diseases related to PM 2.5 pollution
Source: https://www.nationthailand.com© 2018 National Center for Global Health and Medicine

13
13

Thailand health burden (Cont.)oAMRoTB, RR-/MDR-TB
oHepatitis B
oDengue• Thailand show the potential for conducting the clinicalresearch in dengue due to there are various type of patiente.g. naïve patients and secondary dengue infected patients• Dengue vaccination related research : well established1) b
In 2019, the dengue case is around
114,449 cases with 122 case death(until 11 Nov.) which is highest caseduring 5 years.

© 2018 National Center for Global Health and Medicine• There are many AMR strain founded in Thailand and somehave been collected in biobank. So Thailand is ready for the
innovation for AMR testing14
14© 2018 National Center for Global Health and Medicine

Current situation of research and development
on communicable and non-communicable diseases(Our personal opinions)17
17

Unmet needs of R&D
1.
2.
3.
4.

3.1 Communicable diseases
v HIV researchvNew regimen/to cure HIV

v Hepatitis B
v Denguev Malaria
v TB

Accessibility of the new cancer treatment/early diagnosis
Patient accessibility to participate in the clinical trial
Awareness of antimicrobial resistance (AMR)
Under screening for the preventable diseases
e.g. breast cancer, cervical cancer

5. Under detection of the early stage of some diseases

3.2 Non-communicable diseases

Glaucoma, DM, CAD, AF

v Cancerv Cardiovascular diseases: HT, CAD: anticoagulants
v Metabolic diseases e.g. DM
v Road traffic accident prevention study : ?

© 2018 National Center for Global Health and Medicine

16

Current situation of research and development
on communicable diseases

2) Communicable diseases

Hepatitis B

16© 2018 National Center for Global Health and Medicine

6. Need (short/long term) policies to reduce the rate of roadtraffic injury/ pollution prevention

15
15© 2018 National Center for Global Health and Medicine(Our personal opinions)18
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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition81

Proposed solutions to fill the gaps

Perspectives to fill the unmet needs[From drug and device development perspective]

Researchv Health care system research to strengthening health services
v Increase the number of clinical trials (both IIT, and sponsor trials)

1. Clinical research and drug/device development cano To increase the accessibility of the new treatmentüClinical research (MRCT) might help establishing the
genomic landscape of Thai populationo To meet the need of some specific diseases or problems in Thai(such as mutations in Thai cancers, data on the drug
response that studied in our population)o To collect the specific data of Thai population
populationüIIT related to drug/device development will help lowering
the cost of some treatments/device

Collaboration
v with the local private/governmental institution
v with international health institutions : knowledge sharing© 2018 National Center for Global Health and Medicine(Our personal opinions)19
19

Proposed solutions to fill the gaps (Cont.)

Perspectives to fill the unmet needs

Awareness/preventive planv National plan for prevention program esp.
preventable disease

2. Barriers in Thailand that might related to drug anddevice developmento Antimicrobial resistance control and preventionv Health education/awareness for national-wide
20
20

Proposed solutions to fill the gaps (Cont.)Ø Economy perspectiveo Budget allocation into the researchØ Regarding developing drug/deviceo Less number of IIT
o Need local collaborator© 2018 National Center for Global Health and Medicine

23
23Perspectives to fill the unmet needs (Cont.)[From drug and device development perspective]vHealth education for national-wide populationvHealthcare supporting systems

3. Collaboration which seems possible between Thailand/
institution in Thailand and Japan/NCGMØ Technology transfer
Ø MRCT/ multicenter-RCT

o Increase healthcare personnel
o financial support
o strengthening competency of health care personnel

4. Help/support which could be the efficient collaboration
Ø Innovation
Ø Compact or portable device is very advantageous forremote area and surveillance programØ Japan experiences (regarding trial initiation/management invBudget allocation to healthcare/research system
vInvolve the scientist and healthcare professional in thepolicy making process© 2018 National Center for Global Health and Medicine

22Ø Regulatory perspectiveo Delay processes within the local regulatoryo Contact personnelv Antimicrobial resistance awareness and prevention© 2018 National Center for Global Health and Medicine

22[From drug and device development perspective] (Cont.)o Road- traffic accident long term plano Screening program for the breast cancer and thecervical cancer

82© 2018 National Center for Global Health and Medicine

21
21

drug and device development)© 2018 National Center for Global Health and Medicine

24
24

｜別添 3 / Apendix 3 ｜ 4.

Perspectives to fill the unmet needs (Cont.)

Thai FDA approval related
to the generic drugs?

[From drug and device development perspective]
5. Area/points to learn from Japanese colleagues working in
the clinical research and development field.
• How to prepare the efficient system of clinical trial that
relevant to drug/device for aging society?

Regarding the topical/local applied generic drug /new
generic drug which manufacture and/or import in Thailand

Thai FDA required the comparative studies inpharmacodynamics and/or in clinical together
with in vitro studies.
The applicant need to give the reasons why thesubmitted method is selected.

• Role of drug/device development relating the community caresystem for the aging society© 2018 National Center for Global Health and Medicine

Challenge and Suggestions on Drug or Device Development in Thailand ■25
25

In case the Japanese product needs Thailand’s approval28© 2018 National Center for Global Health and Medicine

28

Situation of clinical trials in Thailand
for additional indication

Ø Oversea clinical study data is acceptableØ Oversea clinical study data is acceptableØ Clinical development (trial) Must aligned with ICH

Ø Must aligned with ICH and/or WHO guidance

and/or WHO guidanceØ Bridging data & local regulatory trials are not always

Ø Bridging data & local regulatory trials are not always

required (exception: drugs that have demonstrated the ethnic

required (exception: drugs that have demonstrated the ethnic

differences might be requested more data)

differences might be requested more data)© 2018 National Center for Global Health and Medicine

26
26

29

Benefits to conduct the clinical trials in Thailandü Well trained research physician, familiar with trials
ü No language barrier for personnel
ü Large naïve patient population across many diseaseprofilesThai FDA approval related
to the generic drugs?
Regarding the systemic generic drug /new generic drug which
manufacture and/or import in Thailand

ü High cost-effectiveness in hosting trials

Thai FDA requires the bioequivalence study and in vitro
dissolution/release study compared to original new drugs
to ensure the quality and efficacy of productü High incidence of tropical diseases
ü Access to state of the art, readily available medical
equipment and facilities infrastructure“Which need to be studied by Thai institution or Thai laboratory
except some which cannot be tested in Thailand”© 2018 National Center for Global Health and Medicine

29© 2018 National Center for Global Health and Medicine

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NOTED: Among ASEAN country, the same dossier can be used
© 2018 National Center for Global Health and Medicine

for submission

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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition83

We thank NCGM for arranging
this productive fruitful meeting –and to meet distinguishparticipants
here in Tokyo 2020.

84© 2018 National Center for Global Health and Medicine

31© 2018 National Center for Global Health and Medicine

32© 2018 National Center for Global Health and Medicine

33

32

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｜別添 3 / Apendix 3 ｜ 5.

Challenge and Suggestions on Drug or Device Development in Vietnam ■5. Challenge and Suggestions on Drug or Device Developmentin Vietnam      

Ngo Van Cong / Thi Hong Linh Le

I. VIETNAMADVANTAGE & DISADVANTAGE
IN CLINICAL TRIALS IN VIETNAM

There are 5 important cities
1. Hanoi (the official capital,
North)
2. Hai Phong (industrial city,
North)
3. Da Nang (Newest emerging
city, Central Vietnam)
HO 4. Ho Chi Minh City (Also
I called Saigon and seen as theAN
Economic Capital, South)
5. Can Tho (heart of the
Mekong Delta)

HA LONG

NCGM, 2020 JAN 24
TOKYO

BEN
THANH

1

Outline4

II. MODEL OF HEALTHCARE SYSTEM

1. Introduction to vietnam

Gov

2. Introduction of health system in vietnam• Ministry of Health (MOH)• MOH Departments• Research Institutes (NIHE, Pasteur Institutes, etc.)• Medical Colleges• National Hospitals (General and specialist)

Province
PeopleCommittee

3. Advantage & disadvantage in clinical trials inDistrict of People Committee• Provincial Health Bureaus• Provincial Hospitals (General and Specialist)• Provincial Preventive Medical Center• Medical Secondary Schools• District Health CentersvietnamCommune Prov. Committee

52

I. VIETNAM

5

II. BACKGROUND AND HISTORY- 1997– 2000, $1 billion was allocated for the

Weather• North: sub-tropical• South: tropical

healthcare sector;

Land areas• 331,200 km2
Population• 93,5 million (2015)• 305 people/km2- 2005–2010, $1.8 billion was spent on building 56
new hospitals;

Main cities• Capital: Ha Noi (7.974 million est. in 2018)• Financial hub: Ho Chi Minh City ( 8.992 million est.
in 2018)
Economy• GDP per capital: $ 2,385 (2017)• GDP growth: 6.6 % (est. from 2017 to 2026)• Commune Health Centers

3

3

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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

85

BACKGROUND AND HISTORY

1938
1900

- Hospitals in Vietnam (1,161 public hospitals and1958

185 private hospitals in 2016);

3201 beds

1919- The number of healthcare clinics and medical

The top referral hospital of
the 37 southern provinces,

1974

centres is increasing (> 20,000 private healthcare

serves a total population of
40 million.

clinics and > 11,000 traditional medicine centres);

710

KEY HOSPITALS IN VIETNAM- 115 People Hospital;- Da Nang Hospital;- Cho Ray Hospital;- Dong Nai Hospital;- Kien Giang Hospital;- Ho Chi Minh Heart Institute;- Ho Chi Minh Oncology Hospital;- UBHN Cancer Centre;- Hue Central Hospital;- K Hospital;- National Institute of Hygiene andEpidemiology Hospital;- Bach Mai Hospital;- Viet Duc Hospital….

36 Clinical
Departments

09 Paraclinical
Departments
11 Functional
Departments- Hanoi and Ho Chi Minh
City are two major
markets for medical
products.
- Cho Ray Hospital, BachMai Hospital

Six Sigma certificate

ISO 15189:2012 Medical Testing Laboratory

8

11

STAFF

CHO RAY HOSPITAL

Staff 3940

Doctors
Nurses872

Technicians
Pharmacists

400
96

Others904

1668

Area 55.000 m2

9

86

12

｜別添 3 / Apendix 3 ｜ 5.

Challenge and Suggestions on Drug or Device Development in Vietnam ■Bach Mai Hospital: History and Development

Daily activities
350 emergency patients
6.000 out-patients
2700 in-patients/day

1911

2000

3.000 in-patients
300 surgeries

2013

2014

2015

2016

2017
1985

Nowadays

BACH MAI HOSPITAL

13

CRH & NCGM COOPERATION ON

16

OVERVIEW OF BACH MAI HOSPITALQUALITY MANAGEMENT & PATIENT SAFETY

Bach Mai Hospital is the first special level general hospital• 3200 inpatient beds
Training course on patient
safety & quality management in 2012

•Total staffs: 3,500•Current structure: 3 Institutes, 11 Centers, 22 Clinical
Departments and 5 Paraclinical Departments, 12 Functional
Divisions, 1 Medical College, 2 other units, 1 Journal of
Clinical Medicine.

Training course on QM & PS at CRH• Creadited Laboratory ( ISO 15189:2007)
Training course by WHO and NCGM in 2016

14

17

Number of outpatient in 5 years

TECHNICAL ASSISTANT PROJECT

1. On job training in Hospital Quality
Management and Patient Safety
2. Lectures
3. Research
4. Training in Japan
Summary meeting at CRH on 14th Dec 201615

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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition87III. CLINICAL TRIALS IN VIETNAM

Number of inpatient in 5 years- Vietnam isparticipating inapproximately 7–8 new
industry sponsored
trials every year.
- There were 142 trials

19

III. REGULATORY APPROVAL PROCESS IN VIET NAM

22

NUMBER OF CLINICAL TRIALS (2015 -2019)
50
45
40

47
40

40

35
30

30

27

25
20
15
10
5
0

20

2016 Category
2017 12018

2019

Interventitional clinical trial in HCM, HNC

23

NUMBER OF CLINICAL TRIALS IN THE ASIA REGION

III. NUMBER OF CLINICAL TRIALS

21

88

2015

Source: www.clinicaltrials.gov (accessed 20 July 2011)24

｜別添 3 / Apendix 3 ｜ 5.

Challenge and Suggestions on Drug or Device Development in Vietnam ■ADVANTAGE
-

Wide

range

of

diseasesandpotential patient pool;- Improvement:+ Timeline start-up- Adequate facilities (central);+ Clinical trial experience- Qualified staff (medical license; GCP

of provincial or district

Certificate for Central Hospitals andInstitutes);- Experience (National Hospitals andhealth care centers+ Facilities of district
hospitals in remote areas

Institutes);
2
5- Cost saving and low competitors

25

28

DISADVANTAGE- CSA needs to be translated into the local language
as legal documents;- Some basic researching fees (10% administrative feesfor MOH and 30% overhead fee included in CSA);- Too much steps in researching:

Clinical Trials is increasing about
quantity and quality+ Requirement of renewing IL yearly and renewing EL for biosamples
every 6 months;+ Restriction of relabeling IMP/non-IMP at sites for shelf-life extension;+ CSR submission requirement for closing study in the country;
à To creates complicated and overlapping procedures for sponsors during
the approval process.

26

29

DISADVANTAGE- Network system is weakness;- Need of having local vendor/broker for shortening
IL review process for study specific auxiliaries;- The MOH is in the process of developing
guidelines for best practices in clinical trials;

THANK YOU FOR YOUR ATTENTION!
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Comprehensive and collaborative training on medical innovations adapted to challenges of clinical trials in Asian and African countries | Jan.18-31, 2020 | 2nd edition

89

Comprehensive and collaborative training
on medical innovations
adapted to challenges of clinical trials
in Asian and African countries[2nd edition]
発行 / Issue
令和 2 年 5 月
May, 2020
国立国際医療研究センター
臨床研究センター
インターナショナルトライアル部
National Center for Global Health and Medicine
Center for Clinical Sciences

Department of International Trials

1-21-1 Toyama Shinjuku-ku, Tokyo, Japan 162-8655
Tel ： +81-3-6228-0445 / Fax ：+81-3-6228-0486
E-mail ： dit-info@hosp.ncgm.go.jp

NCGM website：http://www.ncgm.go.jp/

Department of International Trials website ：http://ccs.ncgm.go.jp/050/index.html