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DIA 2021 Global Annual Meeting
Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use
Alison Bateman-House, PhD, MA, MPH
- Assistant Professor, Division of Medical Ethics, Dept of Population Health
- NYU Langone Health, 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.
Holly Fernandez Lynch, JD, MA
- John Russell Dickson, MD Presidential Asst Prof, Medical Ethics & Health Policy
- University of Pennsylvania, United States
Christopher Robertson, JD, PhD, LLM
- N.Neal Pike Scholar and Professor of Law
- Boston University, United States
Paul Aliu, PharmD, MBA, RPh, PMP
- Head Global Governance Office, Chief Medical Office