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Webinar: (2021-08) IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance

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  • Alison Bateman-House, PhD, MPH, MA

    Alison Bateman-House is an assistant professor in the Division of Medical Ethics at NYU Grossman School of Medicine. She is co-chair, with Arthur Caplan PhD, of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning access to investigational medical products and which is composed of patient advocates, clinicians, members of industry, former FDA staffers, lawyers, and academics. She also co-chairs, with Lesha Shah MD, the Pediatric Gene Therapy and Medical Ethics (PGTME) working group, which includes academics, patient advocates, industry representatives, and a wide array of clinical and research professionals. Bateman-House serves as the non-voting, non-paid chair of the NYU/Janssen Pharmaceutical Compassionate Use Advisory Committees (CompACs) for Infectious Diseases and Neurology/Psychology. CompAC won the Reagan-Udall Foundation for the FDA’s 2019 Innovation Award. Bateman-House has published and spoken extensively on how to best handle requests for non-trial access to investigational drugs and on related ethical issues. She has also written and spoken frequently on the history and ethics of using humans as research subjects and on clinical trial accessibility

  • Hayley Belli, PhD, MS

    Hayley Belli is an assistant professor of biostatistics within the Department of Population Health at NYU Grossman School of Medicine, where she conducts research in the design, conduct, and analysis of pragmatic and adaptive clinical trials, including studies embedded within electronic health records, and methods for extracting evidence from real world data in the context of Expanded Access programs. She is a member of the Working Group on Compassionate Use and Pre-Approval Access within the NYU Division of Medical Ethics, and co-chairs the Ethics and Real-World Evidence Research Project.

August 5, 2021
Thu 11:00 AM EDT

Duration 1H 15M

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