MRCT Center Program Director Deborah A. Zarin, MD, and Harry P. Selker, MD, MSP authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy or research decisions in a timely manner.
The MRCT Center submitted public comments to the National Institutes of Health (NIH) “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy,” published in the Federal Register on November 30, 2021.
The MRCT Center appreciates the NIH’s efforts to update its policy on Genomic Data Sharing (GDS) to maintain currency with evolving technology and understanding and commented on multiple issues, including de-identification and evolving concept of “identifiability,” data linkage, data management and sharing principles for NIH-supported resources, harmonization of GDS and NIH Policy for Data Management and Sharing (DMS) plans, and the types of research covered by the GDS policy. In addition, the MRCT Center proposed that the NIH consider several additional issues in its revision including withdrawal of consent, third party risks, harmonization with other federal and international agencies, the increased likelihood of re-identification with future technology advances, sanctions for misuse of data, public education, and the effectiveness and impact of the GDS policy. Read comments
MRCT Center colleagues author an article in JAMA Network Open with Dr. Tony Tse.
Presented on: November 18, 2021
Published by:JAMA Network Open
MRCT Center Executive Director Sarah White, Senior Advisor Luke Gelinas, Project Manager Walker Morrell, Faculty Director Barbara Bierer, and Program Director Deb Zarin authored an article in JAMA Network Open with Dr. Tony Tse: “Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.”
MRCT Center Senior Advisor Luke Gelinas, Project Manager Walker Morrell, Executive Director Sarah White and Faculty Director Barbara Bierer authored an article in Sage Journals: Clinical Trials on “Navigating the ethics of remote research data collection.”
