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December 17, 2003

Results of Clinical Trials Sponsored by For-Profit vs Nonprofit Entities—Reply

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;290(23):3070. doi:10.1001/jama.290.23.3070-a

To the Editor: Dr Als-Nielsen and colleagues1 found that trials funded by for-profit organizations favored the active drug more commonly than placebo. The authors concluded that this may have been due to biased interpretation of trial results. However, an association between funding and study conclusions is not surprising.

A major reason for this, which the authors alluded to briefly, is the "violation of the uncertainty principle," an unfortunate phrase, as it implies error or some nefarious or underhanded activity. There really is no reason to expect that "half of all [published] trials should favor the control intervention." While equipoise may be present in at least some trials sponsored by nonprofit organizations, it is unrealistic to think that there is anything like equipoise in studies sponsored by industry. It is not the business of pharmaceutical companies to do such studies; they are in the business of confirming efficacy. No pharmaceutical company would perform an expensive phase 3 study if it thought the probability of a positive outcome was only 50%. After a positive phase 2 program, one expects a considerably higher probability of success. So it is not surprising that such studies "have a higher likelihood of favoring the experimental drug." In addition, I believe that studies from for-profit organizations, conducted under the watchful eyes of regulatory agencies, are more likely to be better studies (ie, to have adequate double blinding), which would explain the association between double blinding and recommending the experimental drug.

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