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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

Session Chair(s)

Alison  Bateman-House, PhD, MA, MPH

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.

Speaker(s)

Holly  Fernandez Lynch, JD, MA

Panelist

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

Panelist

Christopher Robertson, JD, PhD, LLM

  • N.Neal Pike Scholar and Professor of Law
  • Boston University, United States
Paul  Aliu, PharmD, MBA, RPh, PMP

Panelist

Paul Aliu, PharmD, MBA, RPh, PMP

  • Head Global Governance Office, Chief Medical Office
  • Switzerland