UMIN-Clinical Trials Registry(UMIN-CTR)
Asia Pacific Association of Medical Journal Editors
Convention 2013 ( APAME 2013 Tokyo)
3 August 2013 (Sat), Tokyo, Japan

Kiichiro TSUTANI, MD, PhD
津谷 喜一郎Dept. of Drug Policy & Management, Graduate School of
Pharmaceutical Sciences, The University of Tokyo
1The New York Times 3 June 20042

Prehistory and History of CTR(1976
Meta-analysis in education research)
1993
The Cochrane Collaboration
2000.10 Declaration of Helsinki (Edinburgh)
2004.6 GSK Paxil (paroxetine) scandal
2004.9 ICMJE statement
2004.10 Ottawa statement
2004.10 WHO Int’l CT Registry Platform Meeting, NY2004.11 Ministerial Summit on Health Research, Mexico
2005.1 IFPMA Statement
2005.4 WHO Technical Consultation on CT Registration
Standards Meeting
2005.6 UMIN-CTR established2008.10 Declaration of Helsinki (Seoul)3WHO Trial Registration Data Set(Version 1.2.1)

1. Primary Registry and Trial
Identifying Number
2. Date of Registration inPrimary Registry
3. Secondary Identifying
Numbers
4. Source(s) of Monetary or
Material Support
5. Primary Sponsor
6. Secondary Sponsor(s)7. Contact for Public Queries
8. Contact for Scientific Queries
9. Public Title
10.Scientific Title

11. Countries of Recruitment
12.Health Condition(s) orProblem(s) Studied
13. Intervention(s)14. Key Inclusion and Exclusion
Criteria
15. Study Type
16. Date of First Enrollment
17. Target Sample Size
18. Recruitment Status
19. Primary Outcome(s)20. Key Secondary Outcomes4Symposium on clinical trial registration. At 25th Annual Conference of Japanese Societyof Clinical Pharmacology and Therapeutics. 18 September 2004, Hamamatsu, JapanThe ICMJE statement effectively alerted Japanese investigators.

5• Domestic clinical trial
information will bescattered to overseas’clinical registries if Japan
does not establish its ownregistry.
• Information should be
provided in Japanese forJapanese people foreasier understanding.

6

UMIN Symposium of Clinical Trial Registration. 2 February 2005

http://www.umin.ac.jp/ctr/symposium20050202.htm

7What is UMIN?
• Established in 1989 as a cooperative
organization for national university
hospitals in Japan.
• It is sponsored by the Ministry of Education,Culture, Sports, Science and Technology(MEXT).

8

Cumulative number of registrations in JPRN
(Jun 2005 - Dec 2012)
12,00011,0001,993(17.0%)

JMACCT

10,000108(0.9%)

Registration number9,000
8,000
7,000

6,000

Japic-CTI

5,0009,617(82.1%)

4,000
3,000

UMIN-CTR

2,000
1,0000Date9Three Clinical Trial Registries in JapanJun 2005 UMIN-CTR
The University Hospital Medical Information
Network-Clinical Trials Registry
Jul 2005 Japic-CTI
The Japan Pharmaceutical Information CenterClinical Trials Information
Dec 2005 JMACCTThe Japan Medical Association Center forClinical Trials
10JPRN• WHO launched ICTRP in May 2007.

• According to the policy, only one primary registry from eachcountry is permitted.
• To join the ICTRP network, a study group was granted by
Ministry of Health, Labour and Welfare (MHLW) to establish
an overall search portal for the three Japanese registries.
• This was established in the National Institute of Public Health(NIPH) in October 2007.
• After amendment of a part of registry systems in Japan tosatisfy the requirements of ICTRP, the three registries and thesearch portal cooperate as a whole system and became a WHOICTRP Primary Registry (Japan Primary Registries Network,JPRN) in October 2008.
11

Japan Primary Registries Network (JPRN) search portal
http://rctportal.niph.go.jp/Percentage in ICTRP (total number=206,877 as of 28 Jul 2013)
JPRN: 5.8% ( 11,917)
ClinicalTrials.gov: 68.3%(141,197)

12

Funder type (as of 31 Dec 2012)
8,921 (92.8%)

696 (7.2%)

UMIN-CTR

Non-industry funded: 109 (5.5%)
Industry funded: 1,884 (94.5%)

Japic

Non-industry funded
Industry funded

Non-industry funded: 101 (93.5%)
Industry funded: 7 (6.5%)

JMACCT

01000 2000 3000 4000 5000 6000 7000 8000 9000 10000

UMIN-CTR is the main information source of clinical studies
registered in JPRN, especially for academic (non-industryfunded) studies.
13

UMIN-CTR

Homepage of UMIN-CTR in Japanese
http://www.umin.ac.jp/ctr/index-j.htm
14UMIN-CTR

Homepage of UMIN-CTR in English
http://www.umin.ac.jp/ctr/index.htm
15Registration policies in UMIN-CTR• Objective of registration system(1) Preventing publication bias(2) Fulfilling ethical obligations(3) Providing registration and information in the Japanese
language• What can be registered in UMIN-CTR?
All clinical studies (observational studies included)
UMIN-CTR accepts registration of studies which areconducted outside Japan or registered in foreign registries.
16Registration policies in UMIN-CTR 2• Language
Japanese site included : English & JapaneseJapanese site not included: only English is required• Registration items
Based on WHO’s 20-item dataset and ICMJE requirements,
UMIN-CTR adopts a set of 85 registration items according to
the local needs of information.

• Approximately, 53 items are mandatory items while 32 items
are optional items.
17

Clinical Trial Registration at ClinicalTrials.gov(May-Oct 2005)

Zarin AZ, et.al. NEJM 2005; 353: 2779-87

18

Review of clinical trials registrationin UMIN-CTR(1 Jun 2005 - 18 Jan 2011, 4,774 registrations)
200180Registration number

1601401201008060

ICMJE
announcement aboutclinical trials
registration(Sep 05)

195 (Oct 2010)

Requirement for theapplication of Healthand Labour Sciences
Research Grants (Apr07)

Participation in
ICTRP as a part of
JPRN (Oct 08)

New 5-Year Clinical
Trial Activation Plan
(Mar 07)

40

Revised ICMJE
announcement(Jul 08)

200DateEthical Guidelines
for Clinical Research(Apr 09)

19

Review of clinical trials registration in UMIN-CTR(1 Jun 2005~ 18 Jan 2011, 4,774 registrations)
Country of recruitment
Global(Japan included)
37 (0.8%)

Clinical trial/observational
study

Foreign studies
49 (1.0%)

Japan domestic
4,688 (98.2%)

Observation
study
729(15.3%)

Clinical trial
4,045(84.7%)

20

Review of clinical trials registration in UMIN-CTR(1 Jun 2005-18 Jan 2011, 4,774 registrations)
Sponsor
Pharmaceuticalcompany
50 (1.0%)

Other hospitals
568 (11.9%)

Others (univerisitydepartment, etc.)
432 (9.0%)

OutsideJapan 24 (0.5%)

Others(research group,etc.)
1,341 (28.1%)

Research
institute51(1.1%)

FunderUniversity (Universityhospital included)
2,764 (57.9%)

Profit company352 (7.4%)
Non-profit
foundation
464 (9.7%)

Self funding
2,360 (49.4%)

Government
1,142 (23.9%)21

Source of funding
Category of Organization (select one)
厚生労働省
文部科学省
農林水産省
経済産業省
その他の国の官庁
地方自治体
財団
営利団体
海外自己調達その他

MHLW(JAPAN)
MEXT(JAPAN)
MAFF(JAPAN)
METI(JAPAN)
Other Japanese Government offices
Local Government
Non profit foundation
Profit organization
Outside Japan
Self funding
OtherFor a clinical study conducted without any financial support,
categorize the funding source as “self funding” and register “none” inthe funding source field (text item).

“Sponsor” and “Funder”UMINCTR

Japic-CTI

JMACCT

Clinical
Trials.gov

Sponsor(takes the responsibility
for the initiation,management , and/orfinancing)

実施責任
組織

実施者

主要な実施
責任組織

Sponsor(Lead)

Co-sponsor(provides support for aclinical study withsponsor)

共同実施
組織

(Required)(Required)

共同開発者

Funder
研究費提供 出資の出所(provides funding for the(研究費の組織(Required)clinical study)
名称)(Required)(Required)

共同実施
組織

Collabrator(Required)

研究費提供元(Required)

Only“Fundertype”

Review of clinical trials registration in UMIN-CTR(1 Jun 2005-18 Jan 2011, 4,774 registrations)
Results publication

Prospective/retrospective
registration
Published
183 (3.8%)

Registration first
561 (11.8%)

Recruitment first
4,213 (88.2%)

Partially published(only interim analysis results)
244 (5.1%)

Unpublished
4,347 (91.1%)

24

Kyoto Heart Study retracted (2009)25

ClinicalTrials.gov NCT00149227

26

Kyoto Heart Study was only registered in ClinicalTrial.gov in Englsih.
It is not registered in Japanese registries to be accessible in Japanese.
27

2 July 201228

Challenges posted for UMIN-CTR• Clarification of funding source in registration• Countermeasure against retrospective
registration• Establishment of a system for reporting study
results in UMIN-CTR• Accessibility of Japanese clinical studies inthe Japanese language
29

Acknowledgements• Dept. of Drug Policy & Management,
Graduate School of PharmaceuticalSciences, The University of Tokyo
Fukuzawa Manabu 福澤 学
Tang Wentao唐 文涛

30Thank you

31