Let sun shine on clinical results

The push is on for more transparency in the clinical trial process. A comprehensive registry could help achieve it.

Editorial. July 26, 2004.

Shock waves rumbled through the medical community in February when the Food and Drug Administration convened a hearing to investigate the possibility that certain antidepressants did not help young patients and, in some cases, actually might have increased their risk of suicidal behavior. The previously unavailable clinical trial data that surfaced because of these deliberations changed the understanding of how the medications should be used -- especially among young patients.

It also was part of a series of events, including the agency's initial June 2003 caution regarding the antidepressant paroxetine and second expanded advisory issued in March, that highlighted the life-and-death nature of making clinical trial results more accessible. The unfolding story since has become a rallying cry for efforts to open up the clinical trial process.

The AMA has now added its voice by calling for a specific set of reforms. Concerns long have been simmering over the need for more transparency in the clinical trial process, and the AMA Council on Scientific Affairs put together a compelling case. In a June report, it outlined the potential for publication bias in pharmaceutical research and how such biases threaten to distort the medical literature, thereby affecting the validity and findings of subsequent reviews and analyses and even decisions by government agencies and health plans.