Presentation
Presented by: Barbara Bierer
Presented on: January 23, 2017
Presented to: Health Law Year in P/Review, Harvard Law School, Cambridge, MA
Focus Area: Quality & Transparency
Principles Papers Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:
Return of Aggregate Results to Participants Principles
Principles of Post-Trial Responsibilities: Continued Access to an Investigational Medicine
These short principles documents provide a handy summary of major concepts of larger MRCT Center publications and efforts.
MRCT Center 2016 Impact Report Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
Transparency has been a special focus of the MRCT Center’s 2016 efforts. We introduced detailed plans for Vivli – an independent Center for Global Clinical Research Data – and we developed a principled framework for the return of individual research results to study participants. The 2016 Impact Report also highlights our work on harmonized core competencies for clinical research professionals, post-trial responsibilities, Bioethics Collaborative, and global regulatory efforts in India and China.
MRCT Center 2016 Impact Report
2016 MRCT Center Impact Report
Annual Report
Presented on: December 7, 2016
Presented at: MRCT Annual Meeting
CDISC International Interchange
Presentation
Presented by: Barbara Bierer
Presented on: September 28, 2016
Presented to: Clinical Data Interchange Standards Consortium (CDISC) International Interchange, Washington, DC
Register for the MRCT Center Annual Meeting
The MRCT Center will hold its 2016 Annual Meeting on December 7, 2016, at Harvard Faculty Club’s Loeb House in Cambridge, Massachusetts.
This meeting will present key deliverables of major projects achieved during 2016 and new projects planned for 2017. This offers Executive and Steering Committee and Working Group members as well as interested stakeholders the opportunity to meet face-to-face with each other and learn about current projects of the MRCT Center.
Key themes of the meeting are: Discussion of the impact of the newly released ICH E17 Guidelines and Data Transparency (sharing data with researchers and individual participants).
Draft Principles for Return of Individual Results Available for Comments
A multi-stakeholder work group, led by the MRCT Center, discussed over the last six months issues relevant to returning individual results of clinical trials to participants. We have drafted an initial set of eight principles that are directly relevant to the return of individual results and that are open for comment.
Please see the Return of Individual Results: Principles and Approach document and send comments to MRCT@bwh.harvard.edu by September 1, 2016 with the subject line IRR Principles.
The period for receiving comments is now closed.
Read more about the MRCT Center’s work in returning individual results to participants.
Updated versions of Return of Results Guidance Document and Toolkit released
In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field.
These documents have been revised, and the latest versions are now available:
2016-07-13 MRCT Return of Results Guidance Document Version 2.1
2016-07-13 MRCT Return of Results Toolkit Version 2.2
Please continue to provide feedback and commentary to MRCT@bwh.harvard.edu
Responsible Clinical Trial Data Sharing
Presentation
Presented on: January 28, 2016
Presented at: CBI Conference: Clinical Trial Data Disclosure and Transparency, Philadelphia, PA
A Global, Neutral Platform for Sharing Trial Data
The MRCT Center spearheaded a Perspective in the New England Journal of Medicine that spells out the need and requirements for a global, neutral platform for sharing clinical trial data.
While sharing clinical data is critical to inform clinical and regulatory decision making and to honor trial participants who put themselves at risk, most data generators have no formal mechanism or easily accessible platform for sharing their data, and there has been no organized effort to date to coordinate existing platforms to enable most data generators to share their trial data.
The MRCT Center, working with partners, is currently designing a platform called “Vivli” that will link existing data-sharing platforms and communities while hosting data from investigators who aspire to share their data. Vivli will offer a global, neutral platform to host data securely, with search and data-request services, and will allow for combining of data sets from multiple clinical trials.
A central objective of this global data sharing platform is wide cooperation and collaboration, through inclusion of trials funded and conducted by academia, government, industry, and non-governmental organizations which requires shared governance. Therefore, a wide representation from diverse communities and countries as well as trial participants is needed, and data generators now using other data-sharing platforms will participate in governance.
Read more about the Perspective in the New England Journal of Medicine