Center for Clinical and Translational Science

On April 9, 2025, Dr. Barry Coller, Physician-in-Chief, welcomed Dr. Robert Califf as the 2025 Rufus Cole Lecturer. Dr. Califf is a towering figure in American medicine, combining leadership roles in cardiology and translational science at Duke and health technology at the Google-affiliated company, Verily, along with public service, including twice serving as Commissioner of the U.S. Food and Drug Administration (FDA).

Dr. Coller outlined Dr. Califf’s remarkable career, emphasizing his contributions to medicine, clinical research, and public health policy. He underscored Dr. Califf’s long-standing commitment to evidence-based practice and his leadership at the FDA, where he played a central role in regulating tobacco and addressing the opioid use crisis. 

Dr. Coller also noted the immense scope of the FDA’s work, highlighting the communication challenges the agency faces in conveying complex scientific and regulatory decisions to the public.
During his lecture, Dr. Califf reflected on the evolving landscape of healthcare, emphasizing the need for more effective communication between scientific institutions and the public to rebuild trust in medicine and science. He pointed to the United States’ persistent health disparities and called for a paradigm shift in how evidence is understood and applied in both research and care delivery.

Drawing on his background as a clinician, researcher, and policy leader, Dr. Califf spoke about the rapidly advancing field of healthcare data analysis. He described the growing complexity of organizing medical knowledge and the urgent need for better systems to manage and apply it. He also emphasized the critical importance of centering healthcare around the patient—both in terms of clinical outcomes and data ownership.

Dr. Califf’s credentials are as impressive as they are extensive. He has trained and mentored 112 full-time academic professionals, including three deans, 22 members of the National Academy of Sciences, 46 members of the Association of American Physicians, and five recipients of the prestigious Kober Medal. As the founding director of the Duke Clinical Research Institute (DCRI), he helped pioneer collaborative approaches to clinical trials and translational research. His advisory work spans numerous key institutions, including the NIH, NCI, NHLBI, NIEHS, the National Library of Medicine, and the FDA. At Verily, he served as the head of medical policy and strategy.

Looking forward, Dr. Califf presented a set of key recommendations for the research and healthcare community:

• Enhancing Rare Disease Treatment: Researchers should explore innovative approaches to improve the target and molecule selection for rare disease therapies.
• Evidence in Small Populations: There is a critical need to develop probabilistic models to better assess safety and efficacy in rare disease clinical trials.
• Building Trust in Science: Institutions must explore pathways to restore public confidence in science and healthcare systems.
• Shared Research Infrastructure: Greater collaboration and resource pooling are essential for advancing rare disease research and streamlining clinical trials.
• Funding Innovation: Alternative, sustainable funding models for rare disease treatments should be developed to improve affordability and access.
• Patient-Centered Data Use: Researchers must continue to prioritize the ethical use of patient-centric data while ensuring robust privacy protections.
• System Navigation: Efforts should be made to build more navigable and transparent healthcare systems that support patients and clinicians alike.

Dr. Califf’s Rufus Cole Lecture was preceded by a dinner the night before with Clinical Scholars and Center for Clinical and Translaitonal Science senior staff. He also participated in a Clinical Scholar tutorial before his lecture in which he and Dr. Coller reviewed a paper that they co-authored in 2009 entitled, “Traversing the Valley of Death: A Guide to Assessing Prospects for Translational Success.”

Dr. Califf’s lecture served as both a call to action and a roadmap for the future of healthcare research and policy. As challenges mount in the realms of public trust, data management, and access to care, his insights and recommendations offer a compelling vision for collaborative, patient-focused solutions.