WHO plans global clinical trials registry
■ The international organization hopes to build a comprehensive database in order to prevent the loss of unpublished results.
By Victoria Stagg Elliott — Posted July 26, 2004
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The World Health Organization will be unveiling a global trial registry initiative at its November ministerial meeting on health research in Mexico City, according to statements by organization officials.
"There has been internal work on this issue at WHO for some years to streamline findings information about ongoing unpublished trials," said Metin Gulmezoglu, MD, medical officer at WHO's special program for research in human reproduction.
Several organizations have recently come out in favor of trial registries in the wake of recent controversies about children and the use of antidepressants. Specifically, allegations have emerged that data regarding these drugs' potential risks for young patients may have been concealed.
In June, the American Medical Association urged the U.S. Dept. of Health and Human Services to create a national registry.
The International Committee of Medical Journal Editors is also considering a similar proposal.
But while these American groups have endorsed the creation of a national registry -- one that would be easy to use and include significantly more information than the more than 300 smaller ones in existence -- the WHO would like to take the idea one step further. Its proposal is to set up a global clinical trial registry.
Details of the WHO plan will not be available until the November meeting.
"National registries are a great idea, and that has to be the starting place," said Kay Dickersin, PhD, a professor of epidemiology at Brown University in Providence, R.I., and director of the U.S. Cochrane Center, an independent nonprofit organization that produces systematic reviews of health care interventions.
"Trials are now multinational, and so it's important to know what's going on around the world and how the trials in one country fit in with others," Dr. Dickersin said.
Those backing the AMA proposal are wary about the WHOplan.
"The devil is in the details," said AMA Trustee Joseph Heyman, MD. "But if it's a world registry, it's probably going to be voluntary, and that really won't meet the needs of what we're asking for, which is a centralized registry where every trial is included."
A national registry, for instance, could be sufficient if it required inclusion of all drug trials related to a product working its way through the U.S. approval process -- whether or not those trials occurred here, say supporters of this approach.