Real-World Data Champion Robert Califf Nominated for FDA Commissioner

November 30, 2021

Expanding the use of real-world data is a top priority for Robert Califf, who will have another chance to advance modernized clinical trials if approved to lead the FDA again.


Real-world data is our passion here at COTA, which is one of the many reasons we congratulate Robert M. Califf, MD, on his nomination to lead the Food and Drug Administration (FDA) for the second time.  

Dr. Califf is a staunch advocate for the use of real-world data (RWD) and real-world evidence (RWE) in the clinical trial ecosystem, with a long history of leveraging RWD and RWE to transform the life sciences community.

From his decades as a practicing cardiologist and countless scientific publications to leadership roles at the Duke Clinical Research Institute and numerous other public and private organizations, Dr. Califf has worked tirelessly to educate stakeholders about the importance of using rich, diverse real-world data to support meaningful clinical trials. He brought this perspective to the FDA during his first period of leadership, making real-world evidence the “top programmatic priority” for the agency, he said in 2016

“Unfortunately, too many of the decisions made today about health and healthcare are not supported by high quality evidence,” he said to members of the Food and Drug Law Institute at the time.  His vision was for the FDA to focus on “[real world] evidence generation that can meet the demands of the next few decades” by reliably integrating data from clinical practice into pharmaceutical development.

Since leaving the FDA in 2017, Dr. Califf has continued to push life science stakeholders to focus on diversity and inclusion, improve patient engagement and participation, integrate community medical sites into clinical trials, and reduce administrative fragmentation that leads to higher costs and lower quality research.

While so much has changed in health and life sciences in the few short years since 2017, many things also remain the same.  

We still need to expand the participation of underrepresented and underserved populations in clinical trials. We must continue to develop the technical and regulatory infrastructure to turn real-world data into actionable insights. And we have to improve collaboration across the entire continuum of care to bring breakthrough therapies to patients in a safe, speedy, equitable manner.

The FDA is a critical part of all these goals. COTA is eager to work alongside Dr. Califf and the rest of the agency to build on these concepts and maximize the value and utility of real-world data and real-world evidence in medical research.

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