The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.
The document was endorsed by 36 signatories, including patient advocacy groups and professional associations. This document is currently available for public comment on the FDA website, and we encourage you to comment.
Presented on: August 08, 2017
Published in: Science
Presented on: December 5, 2017
Presented at: Harvard Faculty Club, Loeb House
The MRCT Center is delighted to announce that Vivli has been approved as a 501(c)3 non-profit organization!
The mission of Vivli is to promote, coordinate, and facilitate clinical research data sharing. Vivli will create and implement a global data sharing platform that will serve the international community.
The MRCT Center, in collaboration with Harvard University and the Association of American Medical Colleges (AAMC), released a Sounding Board in the New England Journal of Medicine on the concept of data authorship, a designation and system of credit meant to recognize the efforts the data generators and data sharers.
As we promote the value of cooperation and data sharing, the MRCT Center is conscious of the significant contributions of data generators who voluntarily make their data available for others in the service of public health and scientific advancement. We are aware of both the increasing calls to make data accessible and the absence of a system of credit and recognition for data sharing.
In this just published NEJM Sounding Board, MRCT Center Faculty Co-Director Dr. Barbara Bierer and collaborators from Harvard University and the Association of American Medical Colleges (AAMC) put forward the concept of data authorship as a means for providing academic credit to data generators and incentivizing the sharing of data. This proposal rests on the foundational work of others who have advanced data citation and the FAIR principles, which have made progress possible in the first place.
Read more about the Sounding Board in the New England Journal of Medicine
Presented on: March 29, 2017
Published in: The New England Journal of Medicine
The MRCT Center updated the MRCT Center Return of Aggregate Results Guidance Document and the MRCT Center Return of Aggregate Results Toolkit to incorporate and reflect the EU Guidelines on Summaries of Clinical Trial Results for Laypersons.
In particular, the updates focused on restructuring the content for plain language summaries and the template for returning aggregate results to correspond with the structure and headings that will be required by the EU guidelines. In addition, we updated terminology by adding “aggregate” to the title of the document and referring to Plain Language Summaries rather than research results summaries. We also added additional health literacy resources and links to external resources.
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.
2017-03-07 ANNUAL MEETING Proceedings
2017-12-22 ANNUAL MEETING Slides
Published on: February 16, 2017
Published in: The American Journal of Bioethics
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.
Return of Individual Results to Participants: Principles
These principles build the foundation upon which a more extensive Recommendations Document and Toolkit will be released later this year.
Read more about the MRCT Center’s work on Return of Individual Results.
