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New FDA commissioner plans to apply clinical trials insights gained at Duke

New FDA commissioner plans to apply clinical trials insights gained at Duke


21 March 2016 

By Rachel A. Hardy, MA, RAC

Robert Califf, who was appointed commissioner of the US Food and Drug Administration on 24 Feb is a familiar face for many NC Regulatory Affairs Forum members (FDA 2016). Until recently, he worked as a cardiologist and professor of medicine at Duke University and as a long-term leader of the Duke Clinical Research Institute, where he served as the founding director (DCRI 2015a).

Amid his many duties as commissioner, including oversight of food safety and the marketing of drugs and medical devices, Califf intends to continue improving clinical trials. “I think my record shows that I’m for medical products that work and are effective. When they’re not, I’ve been outspoken,” The Washington Post quoted Califf saying on the day of his confirmation (The Washington Post 2016).

Early last year, Califf joined the FDA as deputy commissioner for Medical Products and Tobacco. Immediately before that, he had been vice chancellor of clinical and translational research at Duke University School of Medicine and director of the Duke Translational Medicine Institute (DCRI 2015a).

At DTMI, Califf lead several efforts to improve clinical trials: the Clinical Trials Transformation Initiative (CTTI) the Measurement to Understand Reclassification of Disease of Cabarrus/Kannapolis (MURDOCK) the Southeastern Diabetes Initiative, the Health Care Systems Research Collaboratory, and the National Patient-Centered Clinical Research Network (PCORnet) (DCRI 2015b). All of these projects aim to make clinical trials more efficient and more effective at solving patients’ problems.

Califf addressed NCRAF in May 2014 on the subject Disrupting Clinical Research: Transforming A System. As FDA commissioner, he has more power than he has ever had to do just that. For a peak into Califf’s thinking, read his slides here (Califf R 2014). And read a short biography here (NCRAF 2014).


US Food and Drug Administration. Meet Robert M Califf MD, Commissioner of Food and Drugs. 25 Feb. 2016. Accessed 29 Feb 2016.

Duke Clinical Research Institute. Duke’s Robert Califf Named as Deputy FDA Commissioner. 26 Jan 2015.,%20director Accessed 29 Feb 2016.

Duke Clinical Research Institute. “A career of innovation.” February 2015. DCRI Newsletter. Accessed 29 Feb 2016.

Dennis B. “Senate confirms Robert Califf as new FDA commissioner. 24 Feb 2016. The Washington Post. Accessed 29 Feb 2016.

Califf R. Disrupting Clinical Research: Transforming a System. Slide presentation as PDF. 2014 NCRAF website. Accessed 29 Feb 2016.

NC Regulatory Affairs Forum. Disrupting the Clinical Research Fabric in the US: A presentation by the Nation’s Premier Clinical Trials Change Agent. 2014. Accessed 29 Feb 2014.

Rachel A. Hardy, MA, RAC, is the vice president of communications of NCRAF. She has more than eight years of experience applying cGCP, including in data management, clinical operations, in a clinic, and in medical writing. She can be reached at [email protected].

Copyright 2016 by Rachel A. Hardy

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