Video: Clinical Trial Data Sharing and Reproducibility

Jeffrey Drazen and Harlan Krumholz discuss the possible benefits and harms of clinical trial data sharing.

There has been ongoing debate regarding the ownership of publicly and privately funded trial data. What are the ethical duties to trial participants? What are the possible benefits and harm of rapid widespread data sharing?

Watch a video of the event below or via the Center for Bioethics YouTube channel.


Health Policy Symposia presenters Jeffrey Drazen, Harlan Krumholz and moderator Ameet Sarpatwari.

(from left)
Jeffrey M. Drazen, MD
Editor-in-Chief, New England Journal of Medicine
Distinguished Parker B. Francis Professor of Medicine, Harvard Medical School

Harlan M. Krumholz, MD, SM
Director, Center for Outcomes Research and Evaluation
Harold H. Hines Professor of Medicine, Yale University School of Medicine

Moderator: Ameet Sarpatwari, JD, PhD
Associate Epidemiologist, Brigham and Women’s Hospital
Instructor in Medicine, Harvard Medical School

Background:
In January 2016, the International Committee of Medical Journal Editors proposed requiring that investigators make de-identified trial data available six months after publication as a precondition of consideration. Many data scientists support the policy and champion even more stringent standards as a means to accelerate scientific advances, tackle the problem of irreproducibility, and fulfill moral obligations to research participants. However, numerous trialists have raised potential challenges in the push toward greater data sharing, including researchers analyzing data with which they are not intimately familiar, diminished incentives for primary data collection, and shared data usability.