Curbing Industry Sponsors’ Incentive to Design Post-Approval Trials that are Suboptimal for Informing Prescribers but more likely than Optimal Designs to Yield Favorable Results

Benjamin P. Falit, Yale University School of Medicine

Abstract

Many studies have shown that commercially sponsored clinical trials are more likely than publicly financed trials to produce results that are favorable to the sponsoring firm. There is no research, however, to support the allegation that industry sponsors intentionally design methodologically inferior studies. Rather than empirically determining whether commercially financed research is less sound than its publicly supported counterpart, this paper focuses on the financial incentives created by the current regulatory climate. This article demonstrates that pharmaceutical companies are being put to a cruel choice between optimally advancing the medical literature and honoring their fiduciary duties to shareholders by designing suboptimal phase IV protocols. As pharmaceutical companies have little incentive to design suboptimal protocols for other types of trials, this article focuses exclusively on non-required post-marketing studies not intended to support supplemental NDA labeling changes. After arguing that the present regime is incapable of reining in conflicted sponsors, it offers both a public and private sector solution that have the potential to align industry interests with the public health.