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Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use
Session Chair(s)
Alison Bateman-House, PhD, MA, MPH
Assistant Professor, Division of Medical Ethics, Dept of Population Health
NYU Grossman School of Medicine, United States
Three routes to access unproven treatments outside of clinical trials will be presented, using Covid-19 as a case study. Presenters will address legal/regulatory, ethical, and pragmatic issues concerning patient care and medical research.
Learning Objective : Discuss three routes - EUA, non-trial preapproval access (Expanded Access and Right to Try), and off-label use of an approved product – by which patients may receive unproven treatments outside of clinical trials; Describe the trade-offs inherent in providing access to unproven treatments in the context of Covid-19.
Speaker(s)
Panelist
Holly Fernandez Lynch, JD, MA
University of Pennsylvania, United States
John Russell Dickson, MD Presidential Asst Prof, Medical Ethics & Health Policy
Panelist
Christopher Robertson, JD, PhD, LLM
Boston University, United States
N.Neal Pike Scholar and Professor of Law
Panelist
Paul Aliu, PharmD, MBA, RPh, PMP
Novartis, Switzerland
Head Global Governance Office, Chief Medical Office