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 100 Trent Drive, Suite401, Davison Building, Durham, NC 27710
Phone (919) 668-9222
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

Kunadian, V, Giugliano, RP, Newby, LK, Zorkun, C, Guo, J, Bagai, A, Montalescot, G, Braunwald, E, Califf, RM, Van de Werf, F, Armstrong, PW, Harrington, R, and Gibson, CM. "Angiographic outcomes with early eptifibatide therapy in non-ST-segment elevation acute coronary syndrome (from the EARLY ACS Trial)." The American Journal of Cardiology 113, no. 8 (April 2014): 1297-1305.

PMID
24607027
Full Text

Lewis, EF, Li, Y, Pfeffer, MA, Solomon, SD, Weinfurt, KP, Velazquez, EJ, Califf, RM, Rouleau, J-L, Kober, L, White, HD, Schulman, KA, and Reed, SD. "Impact of cardiovascular events on change in quality of life and utilities in patients after myocardial infarction: a VALIANT study (valsartan in acute myocardial infarction)." Jacc. Heart Failure 2, no. 2 (April 2014): 159-165.

PMID
24720924
Full Text

Goodman, SG, Wojdyla, DM, Piccini, JP, White, HD, Paolini, JF, Nessel, CC, Berkowitz, SD, Mahaffey, KW, Patel, MR, Sherwood, MW, Becker, RC, Halperin, JL, Hacke, W, Singer, DE, Hankey, GJ, Breithardt, G, Fox, KAA, Califf, RM, and ROCKET AF Investigators, . "Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation)." Journal of the American College of Cardiology 63, no. 9 (March 2014): 891-900.

PMID
24315894
Full Text

Yates, T, Haffner, SM, Schulte, PJ, Thomas, L, Huffman, KM, Bales, CW, Califf, RM, Holman, RR, McMurray, JJV, Bethel, MA, Tuomilehto, J, Davies, MJ, and Kraus, WE. "Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis." Lancet (London, England) 383, no. 9922 (March 2014): 1059-1066.

PMID
24361242
Full Text

Harskamp, RE, Alexander, JH, Schulte, PJ, Jones, WS, Williams, JB, Mack, MJ, Peterson, ED, Gibson, CM, Califf, RM, Kouchoukos, NT, Ferguson, TB, de Winter, RJ, and Lopes, RD. "Impact of extracardiac vascular disease on vein graft failure and outcomes after coronary artery bypass surgery." The Annals of Thoracic Surgery 97, no. 3 (March 2014): 824-830.

PMID
24360877
Full Text

Califf, RM. "Large simple trials: really, it can't be that simple!." European Heart Journal 35, no. 9 (March 2014): 549-551.

PMID
24408889
Full Text

De Ferrari, GM, Fox, KAA, White, JA, Giugliano, RP, Tricoci, P, Reynolds, HR, Hochman, JS, Gibson, CM, Théroux, P, Harrington, RA, Van de Werf, F, White, HD, Califf, RM, and Newby, LK. "Outcomes among non-ST-segment elevation acute coronary syndromes patients with no angiographically obstructive coronary artery disease: observations from 37,101 patients." European Heart Journal. Acute Cardiovascular Care 3, no. 1 (March 2014): 37-45.

PMID
24562802
Full Text

Califf, RM. "Integrated efficacy to effectiveness trials." Clinical Pharmacology and Therapeutics 95, no. 2 (February 2014): 131-133.

PMID
24448458
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 21, no. 4 (January 1, 2014): 578-582.

Full Text

Hess, CN, Roe, MT, Gibson, CM, J Temple, R, Pencina, MJ, Zarin, DA, Anstrom, KJ, Alexander, JH, Sherman, RE, Fiedorek, FT, Mahaffey, KW, Lee, KL, Chow, SC, Armstrong, PW, and Califf, RM. "Independent data monitoring committees: Preparing a path for the future." American Heart Journal 168, no. 2 (January 1, 2014).

Full Text

Pages