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

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dc.contributor.authorKesselheim, Aaron S.en
dc.date.accessioned2022-01-12T13:25:26Z
dc.date.available2022-01-12T13:25:26Z
dc.date.issued2022-01-11
dc.description[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.en
dc.description.abstract[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.en
dc.description.sponsorshipUT Southwestern--Program in Ethicsen
dc.formatMPEG-4 movieen
dc.format.extent01:00:34
dc.identifier.oclc1291719337
dc.identifier.urihttps://hdl.handle.net/2152.5/9662
dc.language.isoenen
dc.subjectGrand Roundsen
dc.subject.meshAntibodies, Monoclonal, Humanizeden
dc.subject.meshAntineoplastic Agentsen
dc.subject.meshDrug Approvalen
dc.subject.meshDrug Developmenten
dc.subject.meshDrug Therapyen
dc.subject.meshLegislation, Drugen
dc.subject.meshProduct Surveillance, Postmarketingen
dc.subject.meshTeaching Roundsen
dc.titleEthical use of surrogate measures in accelerated approval: aducanumab and beyonden
dc.typeVideoen

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