The current clinical research enterprise falls short when answering critical questions for patients, clinicians, and payers to make rational decisions about treatment, and the cost of trials is causing a distortion of investment decisions in new drugs and devices. 

Dr. Rob Califf will discuss efforts to develop a more efficient American clinical trials system. This system would take advantage of quality by design, use more platform trials, and operate through networks in the “real world” to result in trials that are representative of the population while answering critical questions that are patient centered and enable value based reimbursement. 

Date:                                     October 2, 2017

Time:                                    10:00 – 11:00 AM

Location:                              UNC Campus, Bondurant G100

Webinar options:                 Join Skype Meeting

Robert Califf, MD MACC, is the Donald F. Fortin, MD, Professor of Cardiology at Duke University. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from 2015-2016. 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. He is an internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research.

This event is sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) Forum. The ReGARDD affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine, and RTI International.

For information on the requirements to use Skype for Business, visit http://go.unc.edu/LyncMe. The basic requirements are Microsoft Silverlight and speakers or headphones. You will also need to download a small Skype for Business plugin that can be accessed when you join the meeting. More information about connecting is available on the website above. More help.