With the science of clinical trials evolving quickly, Dr. Califf discusses the role and value of clinical trials in medical research. The number of therapeutic interventions is growing, and the need for clear scientific evidence that these interventions work is mounting. Recent emphasis on evidence-based medicine, patient-centered outcomes research, learning, and accountable healthcare systems underscores the fact that most clinical trials fail to provide the evidence needed to inform medical decision-making. The need for a balance between commercial interests and public health is warranted.

Dr. Califf is the vice chancellor for clinical research and director of the Duke Translational Medicine Institute, and professor of medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. He is also the editor in chief of American Heart Journal and is the author or coauthor of more than 1,000 peer-reviewed articles. Dr. Califf also serves as a contributing editor for www.theheart.org, an online information resource for healthcare professionals involved in the diagnosis and management of cardiovascular disease.

He has served on the Cardiorenal Advisory Panel of the U.S. Food and Drug Administration and the Pharmaceutical Roundtable of the Institute of Medicine. He currently serves as co-chair of the Clinical Trials Transformation Initiative, a public-private partnership focused on improving the clinical trials system, and as chair of the Clinical Research Forum, an organization of academic health and science system leaders focused on the improvement of the clinical research enterprise. A member of the National Advisory Council on Aging, he also serves on the Secretary’s Advisory Council on Human Research for the U.S. Department of Health and Human Services. Dr. Califf received his undergraduate degree from Duke University and his M.D. from Duke University Medical School.