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Mark B McClellan

Professor of the Practice of Business Administration
Fuqua School of Business
Margolis Center for Health Policy, JB Duke Buildkng, 230 Science Drive, Durham, NC 27708

Overview


Mark McClellan, MD, PhD, is a physician-economist who focuses on quality and value in health care, including payment and coverage reform, real-world evidence, more effective policies to support drug and device innovation, and initiatives to increase the impact of health care, public health, and social service programs on population health. His work on responding to the COVID-19 public health emergency spanned virus containment and testing strategies, reforming health care toward more resilient models of delivering care, and accelerating the development of therapeutics and vaccines, including a COVID-19 response roadmap. He is former commissioner of the U.S. Food and Drug Administration, and former administrator of the Centers for Medicare & Medicaid Services, where he developed and implemented major reforms in health policy. He has also served as a member of the President’s Council of Economic Advisors and as a Deputy Assistant Secretary for Economic Policy at the Department of the Treasury. He was previously Associate Professor of Economics with tenure at Stanford University.  Dr. McClellan is an independent board member on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; chairs the National Academy of Medicine’s Leadership Consortium for a Value and Science-Driven Health System; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and serves as an advisor for Blackstone Life Sciences, Arsenal Capital Partners, and MITRE.

Current Appointments & Affiliations


Professor of the Practice of Business Administration · 2016 - Present Fuqua School of Business
Director, Duke-Margolis Institute for Health Policy · 2019 - Present Duke-Margolis Institute for Health Policy, University Initiatives & Academic Support Units
Professor of the Practice in the Sanford School of Public Policy · 2016 - Present Sanford School of Public Policy
Associate of the Duke Initiative for Science & Society · 2021 - Present Duke Science & Society, University Initiatives & Academic Support Units
Executive Core Faculty Member, Duke-Margolis Institute for Health Policy · 2024 - Present Duke-Margolis Institute for Health Policy, University Initiatives & Academic Support Units

In the News


Published July 12, 2023
Margolis Family Foundation Gives $10 Million to Duke University to Advance Health Policy Across U.S., World
Published December 18, 2021
Mark McClellan Reappointed as Director of Duke-Margolis Center for Health Policy
Published November 9, 2021
Getting Vaccines from Airports to Arms

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Recent Publications


The New Centers for Medicare and Medicaid Services Patient-Reported Outcome-Based Performance Measure: What It Means and How Can I Align.

Journal Article The Journal of the American Academy of Orthopaedic Surgeons · May 2025 The recognition of the benefits of the measurement and utilization of patient-reported outcome measures (PROMs) in clinical care continues to increase. Furthermore, the Centers for Medicare and Medicaid Services recently mandated a patient-reported outcome ... Full text Cite

A Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators.

Journal Article Pharmacoepidemiology and drug safety · March 2025 BackgroundInternational harmonization of real-world data and evidence (RWD/E) standards is a goal among real-world data/real-world evidence (RWD/E) policy stakeholders. The Duke-Robert J. Margolis Institute for Health Policy developed an online 'I ... Full text Cite
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Education, Training & Certifications


Massachusetts Institute of Technology · 1993 Ph.D.
Harvard Medical School · 1992 M.D.
Harvard University · 1991 M.P.A.
University of Texas, Austin · 1985 B.A.