Robert M. Califf

Professor of Medicine
Donald F. Fortin, M.D. Professor of Cardiology, in the School of Medicine
Member of the Duke Clinical Research Institute
Campus mail 2400 Pratt St Ste 7028, Durham, NC 27705
Phone (919) 668-8820
Email address robert.califf@duke.edu

Robert Califf, MD MACC, is the Donald F. Fortin, MD, Professor of Cardiology. He is also 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.

Associated Faculty Labs

Publications

Piccini, JP, Garg, J, Patel, MR, Lokhnygina, Y, Goodman, SG, Becker, RC, Berkowitz, SD, Breithardt, G, Hacke, W, Halperin, JL, Hankey, GJ, Nessel, CC, Mahaffey, KW, Singer, DE, Califf, RM, Fox, KAA, and ROCKET AF Investigators, . "Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial." European heart journal 35, no. 28 (July 2014): 1873-1880.

PMID
24658769
Full Text

Fleurence, RL, Curtis, LH, Califf, RM, Platt, R, Selby, JV, and Brown, JS. "Launching PCORnet, a national patient-centered clinical research network." Journal of the American Medical Informatics Association : JAMIA 21, no. 4 (July 2014): 578-582.

PMID
24821743
Full Text

Halperin, JL, Hankey, GJ, Wojdyla, DM, Piccini, JP, Lokhnygina, Y, Patel, MR, Breithardt, G, Singer, DE, Becker, RC, Hacke, W, Paolini, JF, Nessel, CC, Mahaffey, KW, Califf, RM, Fox, KAA, and ROCKET AF Steering Committee and Investigators, . "Efficacy and safety of rivaroxaban compared with warfarin among elderly patients with nonvalvular atrial fibrillation in the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)." Circulation 130, no. 2 (July 2014): 138-146.

PMID
24895454
Full Text

Wong, KSL, Hu, DY, Oomman, A, Tan, R-S, Patel, MR, Singer, DE, Breithardt, G, Mahaffey, KW, Becker, RC, Califf, R, Fox, KAA, Berkowitz, SD, Hacke, W, Hankey, GJ, and Executive Steering Committee and the ROCKET AF Study Investigators, . "Rivaroxaban for stroke prevention in East Asian patients from the ROCKET AF trial." Stroke 45, no. 6 (June 2014): 1739-1747.

PMID
24763930
Full Text

Sugarman, J, and Califf, RM. "Ethics and regulatory complexities for pragmatic clinical trials." JAMA 311, no. 23 (June 2014): 2381-2382.

PMID
24810723
Full Text

Steinberg, BA, Hellkamp, AS, Lokhnygina, Y, Halperin, JL, Breithardt, G, Passman, R, Hankey, GJ, Patel, MR, Becker, RC, Singer, DE, Hacke, W, Berkowitz, SD, Nessel, CC, Mahaffey, KW, Fox, KAA, Califf, RM, Piccini, JP, and ROCKET AF Steering Committee and Investigators, . "Use and outcomes of antiarrhythmic therapy in patients with atrial fibrillation receiving oral anticoagulation: results from the ROCKET AF trial." Heart rhythm 11, no. 6 (June 2014): 925-932.

PMID
24833235
Full Text

Holman, RR, Sourij, H, and Califf, RM. "Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes." Lancet (London, England) 383, no. 9933 (June 2014): 2008-2017. (Review)

PMID
24910232
Full Text

"Department of Error." The Lancet 383, no. 9936 (June 2014): 2212-2212.

Full Text

Sherwood, MW, Douketis, JD, Patel, MR, Piccini, JP, Hellkamp, AS, Lokhnygina, Y, Spyropoulos, AC, Hankey, GJ, Singer, DE, Nessel, CC, Mahaffey, KW, Fox, KAA, Califf, RM, and Becker, RC. "Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: Results from the rivaroxaban once daily, oral, direct factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)." Circulation 129, no. 18 (May 6, 2014): 1850-1859.

Full Text

Hankey, GJ, Stevens, SR, Piccini, JP, Lokhnygina, Y, Mahaffey, KW, Halperin, JL, Patel, MR, Breithardt, G, Singer, DE, Becker, RC, Berkowitz, SD, Paolini, JF, Nessel, CC, Hacke, W, Fox, KAA, Califf, RM, and ROCKET AF Steering Committee and Investigators, . "Intracranial hemorrhage among patients with atrial fibrillation anticoagulated with warfarin or rivaroxaban: the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation." Stroke 45, no. 5 (May 2014): 1304-1312.

PMID
24743444
Full Text

Pages