A Global Leader Pioneering Innovative Health ResearchThis presentation material is licensed under a Creative Commons Attribution Non-Commercial
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Medical Information Tsunami

The Information Paradox (Sir Muir Gray)• Incredible developments inbiomedical information generation• Overwhelming volume of data
• Multitude of sources• Each research community speaks its
own scientific “dialect”• Integration critical to achieve promiseof molecular medicine

Medical Information and Knowledge
Rule 31 – Review the world literature fortnightly"Kill as Few Patients as Possible" - Oscar London

5,000per day

1,500
per day
95 perday

Adapted from Paul Glasziou, How do we nurture evidence-based practice?

Number of Clinical Trials by Nation
Country Ranking by the No. of Sites in Clinical Trial Registry ; ClinicalTrials.gov, NLM NIH USA [as of Dec. 2009]2005 (Total 115773)
1 US
2 Canada
3 Germany
4 France
5 UK
6 Italy
7 Japan
8 Spain
9 Netherlands
10 Australia
11 Belgium
12 Poland
13 Sweden
14 Denmark
15 Norway
16 Russia
17 Czech Republic
18 South Africa
19 Brazil
20 Hungary
21 Switzerland
22 Taiwan
23 Finland
24 Mexico
25 Argentina
26 India27 Israel
28 Austria
29 China
30 Greece
31 Portugal
32 Korea

2006 (Total 119085)

61371 US
5870 Germany
5817 France
5666 Canada
3107 UK
2807 Spain
2578 Italy
2321 Japan2319 Poland
2177 Australia
1513 Netherlands
1328 Russia
1255 Belgium
1214 Brazil
937 India
909 Argentina
906 Czech Republic
861 Austria
748 Israel
741 Sweden
718 Hungary
717 Denmark
684 Mexico
625 Korea
619 South Africa
618 China
607 Ukraine
535 Switzerland
459 Romania
393 Finland
381 Taiwan
373 Norway

2007 (Total 115975)

60289 US7324 Germany
5451 France
5150 Canada3956 UK
2961 Spain
2841 Italy
2321 Japan
1725 Poland
1642 Belgium
1591 Russia
1588 Australia
1492 Netherlands
1181 India
1074 Hungary
1064 China
1058 Brazil
1027 Korea
973 Czech Republic
883 Israel
859 Sweden
853 Austria
827 Argentina
820 Ukraine
776 Mexico
774 Denmark
714 Switzerland
571 Taiwan
526 South Africa
470 Greece
460 Finland
418 Romania

2008 (Total 142597)

54263 US
12642 France
4628 Germany
3688 Canada
3403 Japan
3281 Italy
3053 Spain
2200 UK
1823 Russia
1797 Belgium
1792 Poland
1530 Netherlands
1374 Korea
1087 Australia
1001 India
997 China
974 Czech Republic
970 Brazil
948 Sweden
942 Hungary
831 Austria
816 Israel
794 Denmark
742 Romania
712 Argentina
666 Mexico
656 South Africa
640 Greece
607 Taiwan
593 Ukraine
550 Slovakia
546 Finland

2009 (Total 96497)

62426 US
14266 France
9922 Germany
4786 Canada
4392 Spain
3776 Belgium
3548 UK
3240 Italy
2023 Japan
1976 Korea
1963 China
1666 Russia
1582 Poland
1579 Australia
1497 Netherlands
1493 India
1441 Brazil
1348 Sweden
1216 Switzerland
1103 Hungary
1034 Israel
1033 Austria
992 Denmark
992 Taiwan
895 Czech Republic
850 Mexico
800 Slovakia
798 Romania
770 Finland
744 Argentina
688 Greece
623 South Africa

43918
8105
6428
3010
2685
2583
2382
2347
2168
1426
1283
1217
1120
1074
1035
953
865
831
798
753
728
649
641
633
631
605
514
485
477
451
448
434

Clinical Trials in Korea
Data from www.clinicaltrialmagnifier.com

Oncology

308

Cardiology

222

CNS

162

Endocrinology

137

Infectious
Respiratory

112

Kidney/Urology

93

Rheumatology

59

GI & Hepatology

27800

Orthopaedics

25700

Haematology

12

Anaesthesiology & ICU

11

Data from www.Clinicaltrials.gov

503ENT

6O&G

5300

Allergy

3200

Imaging
Other

400

439

434
400

400
327
282
218
193

185

270

126

103
100

13703
670

587

500

83659

600

Dermatology

Ophthalmology

IND Clinical Trials

121

9

7

4351

148

140

820
2005

2006

2007
KFDA

2008
CT-Intervention

2009
2010
CT-Observation

2011

2012

Clinical Research Information Service
http://cris.nih.go.kr

Purpose of CRIS
 To improve transparency and accountability ofclinical researches(trials) to be undertaken inKorea.
 To provide information to the public about clinicalresearches to be undertaken in Korea.
 To provide special search portal and support for
future R&D planning by government, including
priority setting, resource allocation, and otherfunctions

Clinical Research Information Service2008 •Initiate the consensus development

2009
• Feb
• May

System open to public
WHO ICTRP primary registry•Develop the web-accessible public
registry and SOP by KNIH
•Submission for ICTRP primary register2010• Registration Recommended by KFDA

• Feb Mandatory registration of clinicalresearch supported by government.

2011

2012

Registration to CRIS
Account Application

Account Creation
Data Entry

Data Review
Open to public• 40 items which are compatible with globalvariables (WHO Trial Registration Data Set)

• Trial existence: IRB/ERC letters• Internal consistency and logic• Accuracy of study type, arms, interventions,and outcomes• Formatting & spelling

CRIS: Resources Developed and managed by Korea National

Institute of Health, Ministry of Health & Welfare Human resources 4 staffs for maintenance (1 coordinator, 2internal reviewers, 1 IT professional) 6 external advisors
 Financial resources Managed by government

 ~$ 50,000/FY for maintenance & promoting

Clinical Research Information Service

Korea National Institute of Health opened the mobile
website of Clinical Research Information Service(CRIS) onApril 17, 2013.

Cumulative no. of clinical researches
registered into CRIS
No.

800
700
600

500
400
300
200
1000

2010
2Q

3Q

4Q

2011
1Q

2Q

3Q

4Q

Year/Quarter

2012
1Q

2Q

3Q

4Q

2013
1Q

No. of researches (%)
2010

2011

2012

Interventional study

60 (76.9)

145 (64.7)

240 (76.7)

Observational study

18 (23.1)

79 (35.5)

73 (23.3)

Investigator-InitiatedTrial(Research)73 (93.6)

199 (88.8)240 (76.7)

Sponsor InitiatedTrial(Research)

5 (6.4)25 (11.2)

73 (23.3)

Drug37 (61.7)

62 (42.8)

149 (62.1)

Procedure

14 (23.3)

39 (26.9)35 (14.6)

Device10 (16.7)

27 (18.6)

19 (7.9)

Behavior
Dietary Supplement

2 (3.3)0 (0.0)1 (0.7)8 (5.5)

10 (4.2)
10 (4.2)

Study type

Sponsor type †Intervention type ‡Web-site visitors by nation
1% 1% 1% 0%0%
4% 2% 1%
14%76%South Korea
India
United States
ChinaJapan
Singapore
New ZealandUnited Kingdom
GermanyFranceBeyond Clinical Research Registration

Data Sharing & Data
WarehouseClinical Researches

For data sharing,high quality of clinical research isessential.

Clinical Research
Elements of Data Management

 Data Management Plan
 Training CRF Processing/Filing Data Entry
 Validation (Query Generation)
 Query Management
 Audits

Web-Based Clinical Research DataManagement System

iCReaT
Web-based Clinical Research and Trial

iCReaT
Clinical ResearchClinical Research Data Management System

KNIH

Users

Physicians
CRA

Setup

Data Management

QC & DB manager

DMP

Pre Entry Review

DB Quality Check

DB Structure

Data Entry

DB Lock

Data Entry Screen

Data Validation

Data Transfer

Data Validation
Specification

Local DataManager

Medical Coding

Data CollectionClinical Data
Warehouse

Closing

Data
Manager

iCREATClinical Data Management System Developed by Korea NIH
 Open to all clinical researches funded bygovernment
 Support on Training Protocol & CRF development

 eCRF construction
 Query management

Clinical Research Data Repository

Clinical Research Data Repository

Data/Resources sharing
From Repositories

From Repositories

National BioBank
DNA/BloodBank

Tissue Bank

Phenotype
SNP data(GWAS)

clinical researchdata warehouse

Genomec data(NGS)Biochemistry data

Cohortdata

Gene Expression
data
Epigenome data

ICGRC & Clinical Data
Warehouse

MedicalRecordsImage data등

SocialRecord-educational&Social data

Proteome data

HealthStatistics

Willingness to share
Cultural Change

Ability to share
Build a Informatics Platform

Thank you.
• future-oriented• Integrative• Sharing