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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Published Version (Please cite this version)

10.1172/jci146391

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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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Curtis

Lesley H. Curtis

Professor in Population Health Sciences

Lesley H. Curtis is Professor in the Departments of Population Health Sciences and Medicine in the Duke School of Medicine and was inaugural chair of the Department of Population Health Sciences.  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 currently serves as a senior policy advisor at the Food and Drug Administration supporting the Agency’s evidence generation initiative, 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

 

Hernandez

Adrian Felipe Hernandez

Duke Health Cardiology Professor

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