MOVING BEYOND TRANSPARENCY: Recognizing and Managing Conflicts of Interest for Academic Researchers and Institutions Conducting Industry-Sponsored Clinical Trials

Abstract

Academic-industry partnerships in biomedical research come in many forms, but those that occur around clinical research are the most prominent. Researchers at academic medical centers have historically conducted a large proportion of industry-sponsored clinical trials, as they alone had the knowledge, infrastructure, and patient base to design, conduct, and analyze large-scale trials. In recent years, contract-research organizations (CROs) have become popular choices for industry as they offer lower costs, faster trials, and complete industry control of results, but academic investigators are and will continue to be important actors in industry-sponsored clinical trials. Conflicts of interest occur when a set of circumstances creates a risk in which professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. For academic researchers and institutions that conduct industry trials, conflicts of interest are common. Academic institutions and researchers frequently have significant financial interests in industry or marketable research. This stems back to the Bayh-Dole Act of 1980, which gave intellectual property rights developed using federal funding to academic institutions and small businesses in order to spur innovation and translational research, bringing new treatments to market. The Act was a great success but fundamentally altered the missions of universities and academic medical centers, changing them from institutions focused on freely disseminating new and basic knowledge to engaging in profit-guided institutions that focused on marketable research. Much legislation and regulation has focused on identifying and managing conflicts of interest. Both the Food and Drug Administration (FDA) and National Institutes of Health (NIH) have conflict of interest policies for research they fund and oversee. NIH policies affect all institutions that receive Public Health Service (PHS) funding, which includes nearly every university and academic medical center. It requires prospective disclosure of conflicts of interest prior to grant awards and the beginning of research. The FDA, on the other hand, only looks at the financial disclosure statements of non-industry investigators associated with clinical trials after the trials are complete, and it is unclear how much the FDA even uses this post-research oversight. Most troubling about many conflict of interest policies is the tendency to view transparency and disclosure as the end goal, instead of a necessary but insufficient step towards recognition and management of conflicts of interest. Transparency is only meaningful if action is taken as a result of that disclosure. The rebuttable presumption that an individual or institution that holds a significant financial interest in research involving human subjects may not conduct such research except in compelling circumstances is model of such a policy that goes beyond disclosure to regulate action taken as a result of the disclosure. Recommendations centering on the idea that transparency is necessary but not sufficient condition of conflict of interest policy are provided for all stakeholders involved academic investigators conducting industrysponsored clinical trials. Conflicts of interest must be actively recognized and managed, because the nonaligning interests of the multiple parties involved in industry-sponsored clinical trials place a great deal of conflicting pressure on academic investigators. However, the value of having such investigators involved in clinical trials is worth the effort.