UNC School of Law graduate Darpan Patel ’20 was recently awarded first place in the prestigious H. Thomas Austern Writing Competition for his article, “Clinical Trial Data Reporting: Breaking Free of a Prisoner’s Dilemma.”
The competition, sponsored by the Food and Drug Law Institute, is intended to encourage law students interested in the areas of law affecting FDA-regulated industries: food, drugs, medical devices, biologics, dietary supplements, cosmetics, veterinary, cannabis, or tobacco and nicotine products. The top papers in the competition are considered for publication in the Food and Drug Law Journal.
“I was floored when I received the news that I had won the Austern competition,” said Patel. “I hope to practice in food and drug law, so this accolade was especially meaningful to me. None of this would have been possible without the mentorship of Professors Rich Saver and Joan Krause, both of whom offered guidance, support, and sincere intellectual investment in my work as they oversaw the independent studies that gave birth to this paper. And even more so, they always made me feel that, even as a law student, the work I was doing was worthwhile.”
An overview of the winning article:
Clinical trial results form the basis of the Food and Drug Administration’s (FDA’s) approval of medical products for public use. The FDA’s review process is not perfect, however, and agency missteps can harm—sometimes even cost—many lives. In 2007, Congress sought to mitigate these risks by requiring disclosure of trial results to the public registry ClinicalTrials.gov. 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 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 trial results 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. Unlike a normal prisoner’s dilemma, however, 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 research-related and public health benefits of collective compliance with trial data submission requirements.
Read an interview with Patel and learn more about the H. Thomas Austern Writing Competition.