Focus Area: Quality & Transparency

MRCT Center 2017 Impact Report Released

On December 6, 2017, at the MRCT Center Annual Meeting, we released the MRCT Center 2017 Impact Report, Harmonizing the Clinical Trial Ecosystem.

The MRCT Center continued to promote transparency and responsible sharing of clinical trial data. Vivli, the data sharing platform, was incorporated and awarded non-profit, tax-exempt status. The MRCT Center is developing fit-for-purpose prototype templates that will address governance issues in data sharing. Our training efforts have grown significantly this year. We hosted the first pilot training on ICH E6(R2), convening regulators and investigators from 14 countries. The MRCT Center Return of Results Workgroup completed the framework guidance and toolkit, which addresses the complexity of sharing genetic data. We have launched several new projects in 2017, two of which are related to the utility and limitations of real world evidence in regulatory decision-making. On our horizon is a new project to address the lack of diversity in clinical trials.

2017 MRCT Center Progress Report

Plain Language Summary Guidance Document Submitted to the FDA – open for comments

The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants.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.

Read the cover letter

Read and comment on the document

Vivli Attains Non-Profit 501(c)3 Status

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.

Data Authorship as an Incentive to Data Sharing

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

Return of Aggregate Results Version 3.0 Released

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.