Clinical Trial Data Reporting: Breaking Free of a Prisoner’s Dilemma
Clinical trial results form the basis of the Food and Drug Administration’s (FDA’s) approval of medical products for public use. In 2007, Congress began requiring disclosure of clinical trial results to the registry ClinicalTrials.gov in hopes of establishing better oversight and accountability to the public. But even now, results for less than half of all trials are reported on time. Nearly a third are not reported at all. This Article examines how and why many clinical trial sponsors continue not to comply with statutory and regulatory trial results reporting mandates. The ensuing analysis contextualizes the status quo as a prisoner’s dilemma: Due to lack of enforcement pressure and myriad incentives not to report clinical trial results, noncompliant trial sponsors may consider themselves to “win” when they do not disclose, but others do. As with any prisoner’s dilemma, when parties seek to act in their best interest at the expense of others, everyone loses—including the very parties that thought they were coming out ahead. But unlike a normal prisoner’s dilemma, losses in the context of clinical trial data reporting are not limited to the involved parties. Attritive behavior by noncompliant trial sponsors harms all stakeholders in the medical research enterprise by rendering inaccessible the significant research-related and public health benefits of collective compliance with trial data submission requirements.
Food and Drug Law Journal
Volume 76, Number 1