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

Deursen, Vincent M. van, Adrian F. Hernandez, Amanda Stebbins, Vic Hasselblad, Justin A. Ezekowitz, Robert M. Califf, Stephen S. Gottlieb, et al. “Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: results from the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF).” Circulation 130, no. 12 (September 16, 2014): 958–65. https://doi.org/10.1161/CIRCULATIONAHA.113.003046.

PMID
25074507
Full Text

Hess, Paul L., Michael J. Mirro, Hans-Christoph Diener, John W. Eikelboom, Sana M. Al-Khatib, Elaine M. Hylek, Hayden B. Bosworth, et al. “Addressing barriers to optimal oral anticoagulation use and persistence among patients with atrial fibrillation: Proceedings, Washington, DC, December 3-4, 2012.” Am Heart J 168, no. 3 (September 2014): 239-247.e1. https://doi.org/10.1016/j.ahj.2014.04.007.

PMID
25173533
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Harskamp, Ralf E., John H. Alexander, Phillip J. Schulte, Colleen M. Brophy, Michael J. Mack, Eric D. Peterson, Judson B. Williams, et al. “Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial.” Jama Surg 149, no. 8 (August 2014): 798–805. https://doi.org/10.1001/jamasurg.2014.87.

PMID
25073921
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Girgis, I. G., M. R. Patel, G. R. Peters, K. T. Moore, K. W. Mahaffey, C. C. Nessel, J. L. Halperin, R. M. Califf, K. A. A. Fox, and R. C. Becker. “Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF.” J Clin Pharmacol 54, no. 8 (August 2014): 917–27. https://doi.org/10.1002/jcph.288.

PMID
24668660
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Hess, Connie N., Matthew T. Roe, C Michael Gibson, Robert J. Temple, Michael J. Pencina, Deborah A. Zarin, Kevin J. Anstrom, et al. “Independent data monitoring committees: preparing a path for the future.” Am Heart J 168, no. 2 (August 2014): 135-41.e1. https://doi.org/10.1016/j.ahj.2014.05.003.

PMID
25066551
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Bernardez-Pereira, Sabrina, Renato D. Lopes, Maria Julia Machline Carrion, Eliana Vieira Santucci, Rafael Marques Soares, Matheus de Oliveira Abreu, Ligia Nasi Laranjeira, et al. “Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the ClinicalTrials.gov registry.” Am Heart J 168, no. 2 (August 2014): 213-9.e1. https://doi.org/10.1016/j.ahj.2014.04.013.

PMID
25066561
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Blazing, Michael A., Robert P. Giugliano, Christopher P. Cannon, Thomas A. Musliner, Andrew M. Tershakovec, Jennifer A. White, Craig Reist, Amy McCagg, Eugene Braunwald, and Robert M. Califf. “Evaluating cardiovascular event reduction with ezetimibe as an adjunct to simvastatin in 18,144 patients after acute coronary syndromes: final baseline characteristics of the IMPROVE-IT study population.” Am Heart J 168, no. 2 (August 2014): 205-12.e1. https://doi.org/10.1016/j.ahj.2014.05.004.

PMID
25066560
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Piccini, Jonathan P., Jyotsna Garg, Manesh R. Patel, Yuliya Lokhnygina, Shaun G. Goodman, Richard C. Becker, Scott D. Berkowitz, et al. “Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.” Eur Heart J 35, no. 28 (July 21, 2014): 1873–80. https://doi.org/10.1093/eurheartj/ehu083.

PMID
24658769
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Halperin, Jonathan L., Graeme J. Hankey, Daniel M. Wojdyla, Jonathan P. Piccini, Yuliya Lokhnygina, Manesh R. Patel, Günter Breithardt, et al. “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 8, 2014): 138–46. https://doi.org/10.1161/CIRCULATIONAHA.113.005008.

PMID
24895454
Full Text

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