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Tips for optimizing life sciences board oversight over clinical trials

John Barker (jbarker@bonarinstitute.com) is a Senior Associate at the Bonar Institute in Ottawa, Canada; and Wheeling, IL.

Life sciences companies wanting to market new drugs, biological products, and medical devices across state lines must conduct clinical trials to obtain approval from the U.S. Food and Drug Administration (FDA) to do so.[1] These companies’ compliance professionals and board members face unique and evolving compliance challenges. This article provides practical tips for board members and compliance professionals for optimizing clinical trial oversight. It first reviews the fundamental duty established in the Delaware case of In re Caremark to monitor a corporation’s legal and regulatory compliance and business performance.[2] Second, it discusses the lack of guidance for life science companies in Caremark. Third, it provides practical suggestions for life sciences companies’ boards and compliance professionals for fulfilling Caremark oversight duties based on analysis of two cases, Marchand v. Barnhill[3] and In re Clovis Oncology,[4] as well as a review of advice from legal scholars and compliance professionals. It offers suggestions for identifying compliance risks associated with clinical trials. Finally, the article notes challenges that arise from the differing perceptions of Caremark duties between compliance professionals and board members, as well as the effect of other incentives to fulfill monitoring duties.

The article does not provide tax, accounting, or legal advice but instead aspires to contribute to fulfilling the compliance profession’s duties “to the general public, to employers and clients, and to the legacy of the profession,” as noted in the preamble to the Code of Ethics for Health Care Compliance Professionals.[5]

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