Display Settings:

Format

Send to:

Choose Destination
We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
J Evid Based Med. 2009 Feb;2(1):1-7. doi: 10.1111/j.1756-5391.2009.01014.x.

From Mexico to Mali: four years in the history of clinical trial registration.

Author information

  • 1International Clinical Trials Registry Platform, Research Policy & Cooperation Department, World Health Organization, Geneva, Switzerland. ghersid@who.int

Abstract

In the 4 years between the Ministerial Forums on research and health held in Mexico in 2004 and Mali in 2008, the landscape of clinical trial registration changed significantly. When the ICMJE announced that they would no longer consider publishing the findings of clinical trials unless the research had been prospectively registered, they were key to shifting the way the clinical trials community thinks about research transparency. The argument in favour of greater transparency had been building for more than 20 years. By 2004 there was consistent and convincing evidence of the existence of publication bias and the damage this does to people's ability to make well informed decisions about health care. There is now increasing acceptance that the registration of clinical trials in a publicly accessible registry is a scientific, ethical and moral responsibility. In 2004, less than 3000 clinical trials were registered on databases meeting ICMJE criteria. There are now more than 19000 and, in some countries, prospective registration in a publicly accessible registry is now a legal requirement. Further, since October 2008, prospective registration is required if researchers wish to comply with the Declaration of Helsinki. However, despite these advances and incentives, trial registration in many countries remains far from comprehensive and stronger enforcement mechanisms may be needed in those countries.

© 2009 Blackwell Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

PMID:
21348976
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Blackwell Publishing
    Loading ...
    Write to the Help Desk