Meeting Summary
Released on: January 22, 2019
Developed by: MRCT Center Bioethics Collaborative
Focus Area: Quality & Transparency
Data sharing in the context of community-engaged research partnerships
Publication
Published on: May, 2023
Published in: Social Science & Medicine
Description: As data sharing is expanded in the context of greater community engagement in research, we must ask to whom do benefits of data sharing accrue and to whom do benefits not accrue? In an era of growing efforts to engage diverse communities in research, the impact of data sharing for all research participants and the communities that they represent requires the reassessment of the principles of data sharing, incorporating principles of community-engaged research. This article outlines these considerations and proposes new models of benefit sharing.
Enabling Informed Selection of Clinical Trials
Data Safety Monitoring Board Training Videos
Presentation
Presented on: May 19, 2013
Presented at: Workshops at the Society for Clinical Trials Annual Meeting, Boston
Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials
Publication
Published on: April 4, 2023
Published in: JAMA
Trial termination (the decision to end a trial earlier than planned) has been reported in 17.9% of cardiovascular trials and 16.0% of surgical trials.1,2 Although some trials are terminated for scientific reasons due to safety, efficacy, or futility, many trials are terminated due to inadequate participant enrollment or other nonscientific reasons.
2021 MRCT Center Impact Report
Annual Report
Presented on: December 7, 2021
Presented at: MRCT Annual Meeting
2018 MRCT Center Impact Report
Annual Report
Presented on: December 5, 2018
Presented at: Harvard Faculty Club, Loeb House
Diagnostic Testing for COVID-19: Considering False Positive and False Negative Results by Deborah A. Zarin, MD, MRCT Center Program Director and Joseph Lau, MD
Publication
Published on: April, 2020
Diagnostic tests for COVID-19 are central to most proposed plans for relaxing physical distancing and related policies. The following work by Deborah A. Zarin, MD MRCT Center Program Director and Joseph Lau, MD ,Professor Emeritus of Health Services, Policy and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health serves as a reminder about what we know and don’t know about these tests, how frequently they might produce inaccurate results, and how these inaccuracies might affect their utility in different potential scenarios.
Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed
Publication
Published on: March 30, 2023
Published in: JAMA
Description: This study examined the proportion and timing of results dissemination for registered trials by data source (i.e., ClinicalTrials.gov and PudMed) and funder type.
Timely dissemination of clinical trial results is essential for improving transparency and ensuring that findings are available to inform evidence-based medicine.1 Prior analyses of results dissemination assessed PubMed-indexed publications for National Institutes of Health (NIH)–funded trials completed by 2008; trial results published by academic and industry funders with results posted on ClinicalTrials.gov in 2012; and published or posted results of industry- and nonindustry-funded trials completed by 2015. In this study, the proportion and timing of results dissemination for registered trials were examined by data source (ie, ClinicalTrials.gov5 and PubMed) and funder type…
The MRCT Center Submitted Public Comments to the National Institutes of Health (NIH)
Public Comments
Comments provided on: Februrary 22, 2022
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.