Generating evidence for therapeutic effects: the need for well-conducted randomized trials.
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2020-12-03
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Abstract
In this viewpoint, Robert Califf, former commissioner of the U.S. Food and Drug Administration, and colleagues reflect on how to approach questions about which patient treatments and strategies work, particularly in light of the tremendous pressure on the government and biomedical research enterprise to quickly develop safe, effective therapies during the SARS-CoV-2 pandemic.
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Califf, Robert M, Lesley H Curtis, Robert A Harrington, Adrian F Hernandez and Eric D Peterson (2020). Generating evidence for therapeutic effects: the need for well-conducted randomized trials. The Journal of clinical investigation. 10.1172/jci146391 Retrieved from https://hdl.handle.net/10161/22009.
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Robert M. Califf
Robert Califf, MD MACC, is an Adjunct Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.
Dr. Califf is a Member of the National Academy of Medicine (formerly known as the Institute of Medicine (IOM)) in 2016, one of the highest honors in the fields of health and medicine. Dr. Califf has served on numerous IOM committees, and he has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging.
He has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke's Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory coordinating center and co-PI of the Patient Centered Outcomes Research Institute Network.
Lesley H. Curtis
Lesley H. Curtis is Chair and Professor in the Department of Population Health Sciences and Professor in Medicine in the Duke School of Medicine. A health services researcher by training, Dr. Curtis is an expert in the use of health care and Medicare claims data for health services and clinical outcomes research, and a leader in national data quality efforts. Dr. Curtis has led the linkage of Medicare claims with several large clinical registries and epidemiological cohort studies including the Framingham Heart Study and the Cardiovascular Health Study. Dr. Curtis recently served as a senior policy advisor at the Food and Drug Administration supporting the Agency’s evidence generation initiative, serves as an Investigator in the Coordinating Center for PCORI's PCORnet, and is co-PI of the NIH Pragmatic Trials Collaboratory, an NIH initiative to strengthen the national capacity for large-scale research studies embedded in health care delivery.
Areas of expertise: Health Services Research and Health Policy
Adrian Felipe Hernandez
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