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

Kaul, Padma, Jean-François Tanguay, L Kristin Newby, Judith S. Hochman, Cynthia M. Westerhout, Robert M. Califf, Pierluigi Tricoci, et al. “Association between bleeding and mortality among women and men with high-risk acute coronary syndromes: insights from the Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes (EARLY ACS) trial.” Am Heart J 166, no. 4 (October 2013): 723–28. https://doi.org/10.1016/j.ahj.2013.07.014.

PMID
24093853
Full Text

Alexander, Karen P., David F. Kong, Aijing Z. Starr, Judith Kramer, Karen Chiswell, Asba Tasneem, and Robert M. Califf. “Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov.” J Am Heart Assoc 2, no. 5 (September 26, 2013): e000009. https://doi.org/10.1161/JAHA.113.000009.

PMID
24072529
Full Text

Gottlieb, Stephen S., Amanda Stebbins, Adriaan A. Voors, Vic Hasselblad, Justin A. Ezekowitz, Robert M. Califf, Christopher M. O’Connor, Randall C. Starling, and Adrian F. Hernandez. “Effects of nesiritide and predictors of urine output in acute decompensated heart failure: results from ASCEND-HF (acute study of clinical effectiveness of nesiritide and decompensated heart failure).” J Am Coll Cardiol 62, no. 13 (September 24, 2013): 1177–83. https://doi.org/10.1016/j.jacc.2013.04.073.

PMID
23747790
Full Text

Reith, Christina, Martin Landray, P. J. Devereaux, Jackie Bosch, Christopher B. Granger, Colin Baigent, Robert M. Califf, Rory Collins, and Salim Yusuf. “Randomized clinical trials--removing unnecessary obstacles.” N Engl J Med 369, no. 11 (September 12, 2013): 1061–65. https://doi.org/10.1056/NEJMsb1300760.

PMID
24024845
Full Text

Lopes, Renato D., Jennifer A. White, Pierluigi Tricoci, Harvey D. White, Paul W. Armstrong, Eugene Braunwald, Robert P. Giugliano, et al. “Age, treatment, and outcomes in high-risk non-ST-segment elevation acute coronary syndrome patients: insights from the EARLY ACS trial.” Int J Cardiol 167, no. 6 (September 10, 2013): 2580–87. https://doi.org/10.1016/j.ijcard.2012.06.053.

PMID
22795720
Full Text

Piccini, Jonathan P., Susanna R. Stevens, Yuchiao Chang, Daniel E. Singer, Yuliya Lokhnygina, Alan S. Go, Manesh R. Patel, et al. “Response to letter regarding article, "renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R2CHADS2 index in the ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) study cohorts".” Circulation 128, no. 11 (September 10, 2013): e172–73. https://doi.org/10.1161/CIRCULATIONAHA.113.004013.

PMID
24019452
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
Full Text

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
Full Text

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