Working in a healthcare space marked by such “rapid growth in technology and knowledge” has fostered a conundrum: There is “so much potential and also so much risk,” he said. “The digital world and understanding of how to engage people [is converging] in many ways. At the same time, this same convergence raises serious questions about our approach to clinical research, health and healthcare.”
In Sum
“If we want essential insights about what it is like to live with a disease, the outcomes that matter, and the adequacy of treatment options, we should ask people who are living with the problem or at risk of experiencing the problem — both patients and caregivers,” he said. “We should be able to design a more accurate, more complete benefit-risk framework that helps us to better evaluate the safety and effectiveness of a medical product across the vast expanse of patients and consumers with different values, educational levels and living and healthcare environments. We need to ensure that the experience of living with the disease is factored explicitly into development programs for all medical products, including measures of benefit and harms within clinical trials.”
Dr. Califf was sworn in as the FDA’s 25th commissioner in February 2022, after serving in the same role from February 2016–January 2017. He previously was the FDA’s deputy commissioner for medical products and tobacco, head of medical strategy and senior advisor at Alphabet Inc. and director of the Duke University Translational Medicine Institute, Durham, N.C., and Duke’s Clinical Research Institute. He earned his medical degree from Duke’s School of Medicine and completed his residency in internal medicine at the University of California-San Francisco and a cardiology fellowship at Duke.
The Patient Engagement Symposium is an annual event hosted by the NHC.
Ryan Basen is a journalist, writer and editor in Washington, D.C.
