Focus Area: Quality & Transparency

Recent Publications

Dr. Barbara Bierer, MRCT Center Faculty Director, co-authored Development of a Plain-Language Library of Educational Resources for Research Participants, recently published in the Journal of Clinical and Translational Research.

Dr. Bierer also co-authored Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India which has recently been published by the Journal of Medical Internet Research.

Mr. Mark Barnes, MRCT Center Faculty Co-director, co-authored Will Consent be Disfavored as a Bases for Processing Personal Data in Clinical Research Under EU Data Protection Law? recently published by Bloomberg Law. The article may be accessed by navigating to his bio and scrolling to the bottom of the page for his publications.

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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