Mar 07, 2017
Proceedings and Presentations Available from MRCT Center’s 2016 Annual Meeting
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.