The MRCT Center 2016 Annual Meeting was held on December 7, 2016 and was attended by about 80 stakeholders, including representatives from academia, governmental agencies, institutional review boards, the pharmaceutical industry, and non-profit organizations.
The major themes of the MRCT Center 2016 Annual Meeting included the draft ICH E17 guidelines, data sharing and data transparency, and individual return of results (IRR). The draft ICH E17 guidelines, which delineates guidelines for the development of multi-regional clinical trials (MRCTs) for drug development and approval in regulatory authorities around the world were addressed, and a dynamic group discussion followed. Next, data sharing and data transparency were addressed, including the MRCT Center’s work to create Vivli, an independent non-profit center for global research data and invited speakers shared their insights on this pivotal topic. Dr. Murray Stewart (GlaxoSmithKline), the keynote speaker, addressed the current state of data transparency, and the value of global clinical trial data sharing. Finally, the Individual Return of Results (IRR) Working Group presented two major deliverables, the IRR Recommendation Document and IRR Toolkit, and outlined the eight principles the group has drafted. Invited speakers offered their perspectives and suggested revisions on the MRCT Center’s IRR documents.
Proceedings from this meeting are available and presentations are available for sponsors below.
The MRCT Center Individual Return of Results workgroup developed principles that are directly relevant to the return of individual research results to research participants. These principles are summarized in a brief Principles Document.
On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:
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.
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).
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.
