In 2022-2023, the NIH Pragmatic Trials Collaboratory used its popular PCT Grand Rounds platform to host a special workshop series to examine ethical and regulatory challenges in pragmatic clinical trials. The series included moderated panel discussions, in which the NIH Collaboratory's Ethics and Regulatory Core brought together bioethicists, investigators, and regulatory experts to share lessons learned, discuss empirical findings, and explore remaining uncertainties.
Grand Rounds Sessions
September 9, 2022, 1:00 pm ET: Keynote: Building an Academic Learning Health System: Why Is It So Hard?
Speaker: Steven Joffe, MD, MPH
Moderator: Stephanie Morain, PhD, MPH
October 14, 2022, 1:00 pm ET: Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials
Speakers: Joseph Ali, JD; Leslie J. Crofford, MD; Tanya Matthews, PhD
Moderator: Stephanie Morain, PhD, MPH
November 11, 2022, 1:00 pm ET: Data Sharing and Pragmatic Clinical Trials: Law and Ethics Amidst a Changing Policy Landscape
Speakers: Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics
Moderator: P. Pearl O’Rourke, MD
December 9, 2022, 1:00 pm ET: The Stepped-Wedge Cluster Randomized Trial: Friend or Foe?
Speakers: David Magnus, PhD; Monica Taljaard, PhD
Moderator: Stephanie Morain, PhD, MPH
January 13, 2023, 1:00 pm ET: Ethical Considerations When Vulnerable Populations Are Subjects in Pragmatic Trials
Speaker: Emily A. Largent, JD, PhD, RN
Moderator: Stephanie Morain, PhD, MPH
February 10, 2023, 1:00 pm ET: Informing and Consenting: What Are the Goals?
Speakers: P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD
Moderator: Stephanie Morain, PhD, MPH