Clinical Trials: Causes for Concern and Opportunities for Improvement
By: ROBERT SOLOMON, M.D.
Fifteen years ago the FDA established a registry for clinical trials (www.clinicaltrials.gov) so that scientific investigators and the general public would have a ready source of information about medical research – planned, ongoing, and completed. In 2004 the International Committee of Medical Journal Editors (ICMJE) announced that their journals would publish the results of trials only if they had been registered.
Such a registry is of great potential value to medical scientists who wish to learn whether others are pursuing similar lines of investigation, facilitating their efforts to learn from others’ work even when it has not been published, and potentially enabling collaboration.
In the May 2, 2012, issue of JAMA, Dr. Robert M. Califf and colleagues report their analysis of trials entered in the registry, focusing on cardiovascular, oncology, and mental health research. Their findings reveal some causes for concern but also can be looked upon as opportunities for improvement.
While there was an increase in early registration of trials between the two periods of this analysis (2004-2007 and 2007-2010), fewer than half of trials are registered before enrollment of participants. This directly thwarts one of the major goals of the registry: transparency. Failure to register trials before they are underway suggests that some studies may not be registered if their findings are negative or otherwise unsatisfactory to investigators, sponsors, or sources of funding. A comprehensive registry can overcome publication bias – the tendency for studies with negative or unwelcome findings never to appear in print – only if trials are uniformly entered.
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