Annual Report
Presented on: December 5, 2018
Presented at: Harvard Faculty Club, Loeb House
Focus Area: Quality & Transparency
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.
Approach For Reporting Master Protocol Study Designs on ClinicalTrials.gov: Qualitative Analysis
Publication
Published on: June 10, 2022
Published in: BMJ
Deborah Zarin, MRCT Center Program Director, co-authored “Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis,” published in BMJ. The authors describe an approach for reporting master protocol research programs that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.
MRCT Center 2022 Annual Meeting Slides
You need to be logged in to view this content. Simple Membership is not configured correctly. The login page or the join us page URL is missing in the settings configuration. Please contact Admin
MRCT Center 2022 Annual Meeting Proceedings
Proceedings
Presented on: December 14, 2022
Presented at: “MRCT Center Annual Meeting, Ropes & Gray, Boston, MA
Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions
May 17, 2013 @ 7:30 am – 5:00 pm
In light of recent decisions by the European Medicines Agency (EMA) there is likely to be a call for an increased level of data sharing including from other regulatory agencies. The objectives of this meeting were to provide a forum for discussion of the rationales and implications of this paradigm change and to begin to consider potential solutions.
For more information please see links below.
2013-05-17 P-C MRCT GHI Meeting Proceedings
Deliverables
Projects
MRCT Center Annual Meeting
December 4, 2013 @ 7:30 am – 5:00 pm
The MRCT Center Annual Meeting provided an opportunity to update stakeholders on current initiatives and discuss key Clinical Data Sharing Projects including, Practical Implementation of Clinical Trial Data Sharing and Return of Individual Results to Patients.
For more information please see the links below.
2013-12-04 MRCT Center Annual Meeting Agenda
2013-12-04 MRCT Center Annual Meeting Proceedings
Deliverables
Projects
Promoting Clinical Trial Data Transparency Conference
March 30, 2015 @ 8:00 am – 5:00 pm
During two days, March 30 – 31, 2015 over seventy committed international stakeholders joined together to deliberate how to promote and coordinate clinical trials data transparency.
For more information please see link below
2015-03-31 Data Sharing Conference Agenda
2015-3-31 Data Sharing Conference Proceedings
Deliverables