Clinical trial data: Getting the complete picture

Efforts to ensure that patients and physicians have complete access to study results remain important objectives in the practice of medicine.

Editorial. June 27, 2005.

When it comes to the data pharmaceutical companies gather from clinical trials, physicians and patients now don't know if they have all the information they need to guide treatment plans and drug safety risk-benefit decisions. This concern drives continuing interest in the development of a comprehensive clinical trial registry -- a critical element in ensuring that physicians and patients have access to the best evidence science has to offer.

Recent controversies about antidepressant use by children and teens underscore the need for such a database. They also point to the systemic nature of the problem.

The American Medical Association's Council on Scientific Affairs concluded in a June 2004 report that the existence of publication bias in pharmaceutical research distorts medical literature and therefore could affect the validity of subsequent reviews. This can lead to flawed decisions by government agencies and health plans.

Supporters of a comprehensive repository of trial data say such a mechanism is the answer. Physicians need access to information that would allow them to view the entire picture of how medicines work and they need it in a user-friendly, one-stop shopping, electronically searchable resource.

The AMA has been working toward this goal. Last year the Association called for the creation of a national clinical trial registry operated by the Dept. of Health and Human Services to list all drug trials and link to their results -- both positive and negative. The AMA also urges hospital and university institutional review boards to consider registration of clinical trials as a condition for approval.