International Clinical Trials Registry Platform (ICTRP)

A tool to enhance transparency &accountability of clinical research

Tikki PangResearch Policy & Cooperation

World Health OrganizationGeneva, Switzerland

International Herald Tribune, May 31, 2007

NatureMarch 16, 2006

PLoS Medicine 2008, 5 (11), e217

All new NDA's in 2001 & 2002• Only ¾ of original trials were published• Those with positive outcomes were nearly 5x

as likely to be published as those that were negative

• 41 primary outcomes never published• 17 outcomes published without having first

been discussed in regulatory filings -15/17 made the drugs look better

• Discrepancies between published conclusions from those reported to FDA in ways that favored the new drugs

Nature, May 31, 2008

58th WHA Resolution (2005)“to establish a platform linking a network of international clinical trials registers in order to ensure a single point of accessand the unambiguous identification of trials”

Policy• All trials• Before recruitment of first trial participant

Why register trials?• Addresses publication bias• Contribute to systematic reviews• Increase participation of patients, doctors and

researchers• A scientific, ethical and moral responsibility• Facilitate collaboration between researchers

and coordination between funders - increase effectiveness of the overall research process

• Knowing the denominator • Empowers countries

Manto Tshabalala MsimangMinister of Health, South Africa,World Health Assembly, May 16, 2005

"Clinical trials remain a major concern for us. South Africa is overwhelmed and our people are exposed to too many trials. Regulation, coordination and better access to information on which trials are going on are essential to protect the people"

www.who.int/ictrp

A Network of Registries

AIM: provide a forum for registries to exchange information and work together to establish best practice for clinical trial registration

Platform

Central Database

WHO Trial Registration Data Set

Data providers

ICTRPSearch Portal

Data ModelData Model

Partner registries

95,000 records

ICTRP data providers 2007 - 2009

USA

UKNetherlands

Germany

Iran

India

Sri Lanka

China

Japan

AustraliaPACTR

Potential data providers for the future

Advanced Search

Search results

Universal Trial Number (UTN)Launched in June 2009

Aims to facilitate the unambiguous identification of clinical trials

NOT a

registration number

Permanently attached to the trial

Used whenever information about the trial is communicated

Part of the trial's identity

Documented in the trial protocol

Submitted every time the trial is registered

Should be…

UTN request page

"Bridging"• The problem

–Many multinational trials are recorded in more than one database

• The ideal–One record per trial

• The solution: "bridging"– Group together records about the

same trial

Bridging - ScreenshotsPortal shows that it has found a group of records aboutthe same trial by displaying a plus (+) sign in its search results

Bridging - Screenshots• Clicking on the (+) sign shows the other records (from different

data providers) referring to the same trial • Record with the earliest date of registration is always shown

first

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ArabicSpanishRussianFrenchChineseEnglish

Top 20 Searches (October 2009)

1. Cancer2. Xience3. Multiple Sclerosis4. Breast cancer5. Stimuvax6. Combretastatin7. Kidney cancer8. oxi45039. BLP2510. Liver cancer

11. Diabetes12. p5313. asthma14. India15. Heart failure 16. Stockholm17. Ovarian cancer18. tuberculosis19. Brazil20. United States

1000 new pre-market drug trials every month600 trials registered in the past 2 years

Compliance?

Recent legislationin Brazil andArgentina

April 6, 2009

Future challenges• Involvement of more journals in requesting

registration• Mandating registration in more countries• Triaging registration with ethics review and

regulatory approval in countries• Build capacity-not just to conduct trials but to

manage, register, disseminate• Reporting of trial results• Register of systematic reviews & meta analyses

Ultimate Goal• Improving the transparency and

accountability of the clinical research process– Improving protection of patients rights &

safety– Strengthening the overall efficiency of the

research process– Better decision making– Rebuilding public trust in science

Visit the ICTRP Search Portalhttp://www.who.int/trialsearch/

and send us your comments and suggestions!Thank you