Ethical use of surrogate measures in accelerated approval: aducanumab and beyond


[Note: The slide presentation is not available from this event.] The accelerated approval pathway was designed in the wake of the HIV epidemic to provide a pathway for drugs to reach the market based on showing changes to not-fully-validated surrogate measures. Since then, it has largely been applied to cancer drugs, and became the center of substantial attention with the June 2021 approval of aducanumab for Alzheimer's disease. We will review the ethical tensions at issue in approving drugs based on unproven surrogate measures, and consider how the accelerated approval pathway has been implemented.

General Notes

[Note: The slide presentation is not available from this event.] Tuesday, January 11, 2022; noon to 1 p.m. (Central Time); via Zoom. "Ethical use of Surrogate Measures in Accelerated Approval: Aducanumab and Beyond". Aaron S. Kesselheim, M.D., J.D., M.P.H., Professor of Medicine at Harvard Medical School and Director of the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital.

Table of Contents


Grand Rounds, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Drug Approval, Drug Development, Drug Therapy, Legislation, Drug, Product Surveillance, Postmarketing, Teaching Rounds


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