Financial Conflicts of Interest in Clinical Trials

Abstract

Because clinical trials are the gold standard for evaluating the safety and efficacy of drugs and medical devices, they should be conducted as safely and objectively as possible. Objectivity can be affected by study design and conduct, but additional risks to objectivity – and possible risks to safety – may arise from financial conflicts of interest (FCOIs). The explosion in recent decades of financial relationships between medical researchers and the pharmaceutical and medical device industry means it is very likely that at least some members of most clinical trial study teams will have a financial tie with the sponsor or manufacturer of the study drug or device. Payments of various types are ubiquitous. The data on payments to physicians published by the Center for Medicare and Medicaid Services (CMS) since 2014 offers evidence that approximately half of all physicians have financial ties with industry (Tringale et al. 2017). Social science studies have demonstrated that financial interests can give rise to conscious or unconscious bias in favor of the product being tested or its manufacturer. In addition, when institutions that are clinical trial sites have financial interests related to a clinical trial, the institutional conflicts of interest (institutional COIs) can create risks to the objectivity or safety of the study. So close attention to conflict of interest issues is essential for protecting the integrity of clinical trials. This chapter will examine the nature of the risks at issue, key regulations and standards for addressing FCOIs in research, key elements of FCOI policies, and approaches to evaluating and addressing FCOIs.