Harvard Schering-Plough Workshop

Robert M. Califf, M.D.

Vice Chancellor for Clinical Research, Duke University Medical Center

Money, Ethics, Culture of Practice and Genetic Variation: Unresolved Issues in Globalization of Clinical Trials in 4 Dimensions

Abstract

Pharmaceutical and device companies have embraced globalization as a core component of their business models, especially in the realm of clinical trials. This phenomenon raises important questions about the economics and ethics of clinical research and the translation of trial results to clinical practice: Who benefits from the globalization of clinical trials? What is the potential for exploitation of research subjects? Are trial results valid and generalizable to the clinical practice settings relevant to patients who will use the medical products? In this presentation I will discuss recent trends in and underlying reasons for the globalization of clinical research, highlight scientific and ethical concerns, and propose steps for the harmonization of international clinical research.

Biosketch

Dr. Califf is board-certified in internal medicine (1984) and cardiology (1986) and is a Master of the American College of Cardiology (2006). He is currently Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Institute (DTMI), and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. For 10 years he was the founding Director of the Duke Clinical Research Institute (DCRI) and has led the DCRI for many of the best-known clinical trials in cardiovascular disease. He is the editor-in-chief of Elsevier's American Heart Journal. He has been author or coauthor of more than 900 peer-reviewed journal articles and a contributing editor for theheart.org, an online information resource for academic and practicing cardiologists. He was recently acknowledged as one of the 10 most cited authors in the field of medicine by the Institute for Scientific Information (ISI). Dr. Califf 's role as Director of the DTMI, which is funded in part by an NIH Clinical and Translational Science Award (CTSA), includes service as co-chairman of the Principal Investigators Steering Committee of the CTSA. Dr. Califf has served on the Cardiorenal Advisory Panel of the U.S. Food and Drug Administration (FDA) and the Pharmaceutical Roundtable of the Institute of Medicine (IOM). He was the founding director of the coordinating center for the Centers for Education & Research on TherapeuticsTM (CERTs), a public/private partnership among the Agency for Healthcare Research and Quality, the FDA, academia, the medical-products industry, and consumer groups. He is now the co-chairman of the Clinical Trials Transformation Initiative (CTTI), a public private partnership focused on improving the clinical trials system, founded by Duke and the FDA as part of the Critical Path Initiative.