June 6, 2022: Bioethics Supplement to Address Data Sharing and Pragmatic Clinical Trials

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Stephanie Morain shared information about a bioethics supplement designed to explore the ethical issues that arise in the context of pragmatic clinical trials (PCTs) and data sharing.

 

“Our goal with the supplement is to identify the ways in which existing policies to promote data sharing do or do not align with the specific needs of pragmatic clinical trials.”

The activities of the bioethics supplement are to:

  • Conduct a systematic literature review to identify the specific features PCTs that may alter the risk-benefit calculus for data sharing as compared to explanatory trials & other settings with ethically relevant similarities
  • Through stakeholder interviews, explore data sharing in PCTs as understood by those responsible for the oversight, generation, dissemination, and future use of PCT data
  • Evaluate existing and proposed policies and guidance to promote data sharing.

Dr. Morain is a member of the Ethics and Regulatory Core of the NIH Pragmatic Trials Collaboratory, and this work is part of an overarching goal to develop approaches to the ethical design and conduct of pragmatic clinical trials.

Read Dr. Morain’s presentation on the Bioethics Supplement given at the Steering Committee Meeting in April.

Headshot of Dr. Stepanie Morain
Dr. Stepanie Morain