Digital Clinical Trials and Private Equity Firms: Tensions Between Efficiency and Drug Evidence Access
This talk is based on the Digital Clinical Trials and Private Equity Firms book chapter in a forthcoming volume “Health Law as Private Law,” edited by the Harvard Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The essay intervenes in scholarly discussions about the decentralization of clinical trials, asking whether the rapidly growing interest of private equity firms in the medical research space is conducive to the goal of making scientific evidence and safe and effective medicine widely accessible. The essay examines the purpose of clinical trial decentralization and the acute use of technology to recruit and interact with trial participants in remote sites and identifies the business incentives of private equity firms in medical research. As such, the essay identifies the social and economic tensions between the maximization of profits and the maximization of safety around the production of scientific evidence, risking safe and effective medicines from reaching the market. The essay concludes that private equity firms digitizing clinical trials might aggravate the problems of data opacity of medical research in the U.S., thereby undermining the safety, efficacy—and accessibility—of drugs.
Speaker
Dr. Ximena Benavides, J.S.D., LL.M., LL.B.
Lecturer and Postdoctoral Associate, Ethics, Politics, and Economics Program, Yale University
Information Society Project Postdoctoral Resident Fellow, Yale Law School
Ximena Benavides is a Postdoctoral Associate and Lecturer at Yale University's Department of Political Science in the Ethics, Politics & Economics Program. She is also a Resident Fellow at the Information Society Project of Yale Law School and affiliated faculty at the Yale Institute of Global Health. Her research focuses on the intersections of law, public policy, and political economy of life sciences innovation, particularly in the areas of information and industrial policies for access to quality medicine, both domestically and in a global context, with a health justice approach. Currently, she is working on the CIHR-PHAC Infectious Disease Innovation Governance project at the Health Law Institute of Dalhousie University's Schulich School of Law, conducting qualitative empirical research on the WHO's mRNA technology transfer program. In 2021, as a Yale Institute for Global Health Fellow, she worked for GAVI, COVAX Facility during the distribution of COVID-19 vaccines.
Dr. Benavides was born in Peru, where she received her law degree magna cum laude and was an Adjunct Law Professor. She holds a Master of Laws (LL.M.) and a Doctor of the Science of Law (J.S.D.) from Yale Law School. Before coming to Yale, Dr. Benavides practiced law for over fifteen years advising governments, multilateral and international organizations, and private actors in cross-border corporate transactions and international arbitration in law firms and the financial industry in New York and countries in Latin America.
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