Robert M. Califf

Adjunct Professor of Medicine
Donald F. Fortin, M.D. Distinguished 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.

Publications

Hess, Connie N., Phillip J. Schulte, L Kristin Newby, Philippe Gabriel Steg, Anthony J. Dalby, Marc J. Schweiger, Basil S. Lewis, et al. “Duration of eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS.” Eur Heart J Acute Cardiovasc Care 2, no. 3 (September 2013): 246–55. https://doi.org/10.1177/2048872612474922.

PMID
24222836
Full Text

Howlett, Jonathan G., Justin A. Ezekowitz, Mohua Podder, Adrian F. Hernandez, Rafael Diaz, Kenneth Dickstein, Mark E. Dunlap, et al. “Global variation in quality of care among patients hospitalized with acute heart failure in an international trial: findings from the acute study clinical effectiveness of nesiritide in decompensated heart failure trial (ASCEND-HF).” Circ Cardiovasc Qual Outcomes 6, no. 5 (September 1, 2013): 534–42. https://doi.org/10.1161/CIRCOUTCOMES.113.000119.

PMID
23899930
Full Text

Preiss, David, Thomas D. Giles, Laine E. Thomas, Jie-Lena Sun, Steven M. Haffner, Rury R. Holman, Eberhard Standl, et al. “Predictors of stroke in patients with impaired glucose tolerance: results from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial.” Stroke 44, no. 9 (September 2013): 2590–93. https://doi.org/10.1161/STROKEAHA.113.001177.

PMID
23899915
Full Text

Gallin, Elaine K., Enriqueta Bond, Robert M. Califf, William F. Crowley, Pamela Davis, Richard Galbraith, and E Albert Reece. “Forging stronger partnerships between academic health centers and patient-driven organizations.” Acad Med 88, no. 9 (September 2013): 1220–24. https://doi.org/10.1097/ACM.0b013e31829ed2a7.

PMID
23887007
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Alexander, John H., Elliott Levy, Jack Lawrence, Michael Hanna, Anthony P. Waclawski, Junyuan Wang, Robert M. Califf, Lars Wallentin, and Christopher B. Granger. “Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial.” Am Heart J 166, no. 3 (September 2013): 559–65. https://doi.org/10.1016/j.ahj.2013.05.025.

PMID
24016507
Full Text

Cai, Qiangjun, Nilay Mehta, Elena B. Sgarbossa, Sergio L. Pinski, Galen S. Wagner, Robert M. Califf, and Alejandro Barbagelata. “The left bundle-branch block puzzle in the 2013 ST-elevation myocardial infarction guideline: from falsely declaring emergency to denying reperfusion in a high-risk population. Are the Sgarbossa Criteria ready for prime time?” Am Heart J 166, no. 3 (September 2013): 409–13. https://doi.org/10.1016/j.ahj.2013.03.032.

PMID
24016487
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Bagai, Akshay, Jennifer A. White, Yuliya Lokhnygina, Robert P. Giugliano, Frans Van de Werf, Gilles Montalescot, Paul W. Armstrong, et al. “Routine early eptifibatide versus delayed provisional use at percutaneous coronary intervention in high-risk non-ST-segment elevation acute coronary syndromes patients: an analysis from the Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome trial.” Am Heart J 166, no. 3 (September 2013): 466–73. https://doi.org/10.1016/j.ahj.2013.05.019.

PMID
24016495
Full Text

Kimmel, Stephen E., Benjamin French, Jeffrey L. Anderson, Brian F. Gage, Julie A. Johnson, Yves D. Rosenberg, Nancy L. Geller, et al. “Rationale and design of the Clarification of Optimal Anticoagulation through Genetics trial.” Am Heart J 166, no. 3 (September 2013): 435–41. https://doi.org/10.1016/j.ahj.2013.04.009.

PMID
24016491
Full Text

Mahaffey, Kenneth W., and Robert M. Califf. “Atrial fibrillation: a spectrum of risk with a uniform treatment effect of novel anticoagulants?” Eur Heart J 34, no. 31 (August 2013): 2429–31. https://doi.org/10.1093/eurheartj/eht205.

PMID
23766419
Full Text

Chan, Mark Y., Jie-Lena Sun, L Kristin Newby, Yuliya Lokhnygina, Harvey D. White, David J. Moliterno, Pierre Théroux, et al. “Trends in clinical trials of non-ST-segment elevation acute coronary syndromes over 15 years.” Int J Cardiol 167, no. 2 (July 31, 2013): 548–54. https://doi.org/10.1016/j.ijcard.2012.01.065.

PMID
22341697
Full Text

Pages