Rebecca Li, PhD
Executive Director, Vivli
Co-Director of Research Ethics, Harvard Center for Bioethics
Harvard Medical School
Frank W. Rockhold, PhD
Professor of Biostatistics and Bioinformatics
Duke Clinical Research Institute
Duke University Medical Center
Preparing for Clinical Trial Data Sharing and Re-use: The New Reality for Researchers
Data sharing; Individual patient data; Open access; Raw data; ICMJE; Research dissemination
- Open access to individual patient data from clinical trials is a critical tool for research in health care. Despite the challenges, the question is not whether data should be shared, but rather how and when access should be granted.
- Preparing data for reuse is often an afterthought—yet it is a new reality for researchers and institutions.
- As of January 1, 2019, the International Committee of Medical Journal Editors (ICMJE) requires registration of a trial’s data sharing plan at the time of trial registration.
- Institutions or teams should begin their data sharing program planning at least 18 months before a major publication (or regulatory approval).
FAIR data are data that meet standards of findability, accessibility, interoperability, and reusability.
How do we manage scientific integrity, replication, and validity given that data sharing opens a study to multiple people asking the same or related questions in potentially different ways using different methods?
How do we plan for a future that rewards data quality and reuse?
#pctGR, @Collaboratory1, @VivliCenter, @FrankRockhold