Clinical Trial Data Sharing and Reproducibility: A Health Policy and Bioethics Consortium
In January, 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.
The ongoing debate has exposed a number of important questions regarding the ownership of publicly and privately funded trial data, our ethical duties to trial participants, and the possible benefits and harm of rapid widespread data sharing.
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, Assistant Director, Program On Regulation, Therapeutics, And Law (PORTAL), Instructor in Medicine, Harvard Medical School
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Learn more about the Health Policy and Bioethics Consortia.
The Health Policy and Bioethics Consortia are hosted and organized by the Harvard Medical School Center for Bioethics and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women's Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Harvard Program in Therapeutic Science. This monthly series convenes international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. Support provided by the Oswald DeN. Cammann Fund at Harvard University.