As a condition of regulatory approval, drug makers are often required to conduct follow-up studies, but sometimes they also voluntarily agree to run still other trials that can yield important information about the safety, effectiveness, and optimal use of new medicines. However, an analysis finds that few such commitments involved new studies and only half were published in peer-review journals.
Specifically, of 110 drugs and biologics that were approved between 2009 and 2012, more than half — or 55.5% — had at least one post-marketing commitment. But only a minority of those post-marketing commitments involved new clinical trials — 33 of 331, or just 10% — as opposed to ongoing studies, according to the analysis that was published in BMC Medicine.
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