When introducing new medical products into clinical care, how do we strike the balance between the need for safety and the desire for access to effective technologies?
On Tuesday, Oct. 17, as part of the RTI Fellow Program Distinguished Lecture Series, Robert Califf—Donald F. Fortin, MD, Professor of Cardiology at Duke University School of Medicine and former Commissioner of the Food and Drug Administration (FDA)—will examine this issue in his seminar “A Systematic Approach to Continuous Evidence Generation and Dissemination of Truthful Information Connected to Expertise.”
Dr. Califf will discuss the need, benefits and challenges of the development of a carefully calibrated point-of-market entry for medical products that ensures that the benefits of using the products outweigh the risks. Factoring in differences between patient populations, he will explain how a comprehensive evidence-generation system could be used to develop rational, situation-specific policies for patients. Dr. Califf will delve deeper into the responsibility of our nation’s universities and public agencies to develop methods that move this system toward scientific truth instead of false or misleading information and explore the importance of disseminating information in a way that drives toward truth and integration of knowledge in concert with domain expertise in the clinical area of interest.
“Dr. Califf is a nationally and internationally recognized expert in cardiovascular medicine, and has led major initiatives aimed at improving methods and data infrastructure for clinical research,” said Sue West , RTI Fellow and Senior Scientist in Social, Statistical, and Environmental Sciences’s Research on Healthcare Value, Equity and the Lifespan (REHVEAL) and one of the organizers of the event. “He will describe his vision for using the currently available surveillance systems and vast amount of existing data to improve the US post-marketing therapeutic safety environment.”
Prior to serving as Commissioner, Dr. Califf was the FDA's Deputy Commissioner for Medical Products and Tobacco. Before joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. Dr. Califf is one of the most cited authors in biomedical science, with more than 1,200 peer-reviewed publications.
Dr. Califf became a Member of the National Academy of Medicine in 2016, one of the highest honors in the fields of health and medicine, and has served as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. He also served on the Board of Scientific Counselors for the National Library of Medicine and 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.