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

Anderson, Monique L., Robert M. Califf, Jeremy Sugarman, and Jeremy participants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop. “Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.” Clin Trials 12, no. 3 (June 2015): 276–86. https://doi.org/10.1177/1740774515571140.

PMID
25733677
Full Text

Roe, Matthew T., Kenneth W. Mahaffey, Justin A. Ezekowitz, John H. Alexander, Shaun G. Goodman, Adrian Hernandez, Tracy Temple, et al. “The future of cardiovascular clinical research in North America and beyond-addressing challenges and leveraging opportunities through unique academic and grassroots collaborations.” Am Heart J 169, no. 6 (June 2015): 743–50. https://doi.org/10.1016/j.ahj.2015.03.002.

PMID
26027610
Full Text

Eapen, Zubin J., Lisa A. McCoy, Gregg C. Fonarow, Clyde W. Yancy, Marie Lynn Miranda, Eric D. Peterson, Robert M. Califf, and Adrian F. Hernandez. “Utility of socioeconomic status in predicting 30-day outcomes after heart failure hospitalization.” Circ Heart Fail 8, no. 3 (May 2015): 473–80. https://doi.org/10.1161/CIRCHEARTFAILURE.114.001879.

PMID
25747700
Full Text

Fordyce, Christopher B., Matthew T. Roe, Tariq Ahmad, Peter Libby, Jeffrey S. Borer, William R. Hiatt, Michael R. Bristow, et al. “Cardiovascular drug development: is it dead or just hibernating?” J Am Coll Cardiol 65, no. 15 (April 21, 2015): 1567–82. https://doi.org/10.1016/j.jacc.2015.03.016.

PMID
25881939
Full Text

Bethel, M. A., J. B. Green, J. Milton, A. Tajar, S. S. Engel, R. M. Califf, R. R. Holman, and R. R. TECOS Executive Committee. “Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS).” Diabetes Obes Metab 17, no. 4 (April 2015): 395–402. https://doi.org/10.1111/dom.12441.

PMID
25600421
Full Text

Anderson, Monique L., Karen Chiswell, Eric D. Peterson, Asba Tasneem, James Topping, and Robert M. Califf. “Compliance with results reporting at ClinicalTrials.gov.” N Engl J Med 372, no. 11 (March 12, 2015): 1031–39. https://doi.org/10.1056/NEJMsa1409364.

PMID
25760355
Full Text

DeVore, Adam D., Vic Hasselblad, Robert J. Mentz, Christopher M. O’Connor, Paul W. Armstrong, John J. McMurray, Justin A. Ezekowitz, et al. “Loop diuretic dose adjustments after a hospitalization for heart failure: insights from ASCEND-HF.” In Eur J Heart Fail, 17:340–46, 2015. https://doi.org/10.1002/ejhf.235.

PMID
25619549
Full Text

Katz, Marcelo, Robert M. Califf, Jie-Lena Sun, John J. V. McMurray, Laine Thomas, and Renato D. Lopes. “Venous thromboembolism and cardiovascular risk: results from the NAVIGATOR trial.” Am J Med 128, no. 3 (March 2015): 297–302. https://doi.org/10.1016/j.amjmed.2014.08.022.

PMID
25447626
Full Text

Lam, Carolyn S. P., Margaret McEntegart, Brian Claggett, Jiankang Liu, Hicham Skali, Eldrin Lewis, Lars Køber, et al. “Sex differences in clinical characteristics and outcomes after myocardial infarction: insights from the Valsartan in Acute Myocardial Infarction Trial (VALIANT).” Eur J Heart Fail 17, no. 3 (March 2015): 301–12. https://doi.org/10.1002/ejhf.238.

PMID
25655011
Full Text

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