Robert M. Califf, MD, MACC, commissioner of the U.S. Food and Drug Administration (FDA), will take the stage today to deliver the ACC.24 Eugene Braunwald Keynote focused on the need to revamp the clinical evidence system.

Califf, who will also be recognized with this year's Presidential Citation during Convocation, has been a driving force throughout his career in the fight against heart disease and other chronic diseases. The accomplished cardiologist, researcher and clinical trials expert has a long and impressive history of prioritizing science and evidence-based policymaking in the best interests of patients and the public.

"It is a true privilege to have Dr. Califf give the Eugene Braunwald Keynote and also be able to honor his unparalleled leadership and vision with the Presidential Citation," said ACC President B. Hadley Wilson, MD, FACC. "He is a true problem-solver, champion of innovation and steadfast advocate of improving heart health for all. The world needs more individuals like him as we work to successfully address the formidable public health challenges that have emerged in the last few decades."

The need for system-wide reform of the clinical research enterprise is one of many challenges that Califf is working to solve. "Closing the enormous gap between what we need to know for evidence-based practice and what we actually know has the potential to enable major improvements in health status," wrote Califf in a 2023 paper published in the Society for Clinical Trials Journal.

According to Califf, "premarket systems for generating and evaluating evidence work reasonably well, but the postmarket phase is disaggregated and often fails to answer essential questions that must be addressed to provide optimal clinical care and public health interventions for all." He advocates for "continued improvements in data science and management, the ethics of data sharing and alignment of purpose in integrating research and clinical practice," and will expand on these ideas during his lecture.

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