Global Clinical Trial Data Sharing
Focus Area: Transparency
In 2015, as part of its commitment to transparency, the MRCT Center and a diverse group of global stakeholders embarked on a mission to define, design, and launch an independent platform to enable global clinical trial data sharing. The solution was later embodied as Vivli, a neutral Center for Global Clinical Research Data Sharing—agnostic to disease, country, sponsor, funder, and investigator— that would establish an independent data repository, analytics platform, and in-depth search engine through which de-identified individual participant-level data (IPD) and metadata from clinical trials conducted by researchers in or supported by academic, industry, foundation, and non-profit entities could be identified, hosted, shared, and analyzed.
As a major project of the MRCT Center, the Vivli concept and governance model was developed through a series of conferences, workgroups, and meetings; Vivli transitioned into an independent non-profit 501c(3) entity as a result of international endorsement and enthusiasm for the concept.
Vivli is the largest global clinical trial platform with over 5,000 trials available to search and request access.
Current Status: Under the Executive Direction of Rebecca Li, Vivli, Inc. is now operating independently of the MRCT Center, functioning as a separate and autonomous Center for Global Clinical Research Data.
Impact: Pharmaceutical and biotech industries, academics, and nonprofits deposit and share clinical trials data seamlessly and effortlessly.
- May 2013: MRCT Center hosts conference with Petrie-Flom Center at Harvard Law School entitled, “Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions” to discuss a framework, taxonomy, and terms for data sharing. A model of a “Learned Intermediary” and independent platform to steward de-identified individual patient-level data, to evaluate data requests, and to provide access to the data was compared to other data-sharing models.
- October 2013: MRCT Center publishes “Preparing for responsible sharing of clinical trial data.” In the New England Journal of Medicine, proposing governance principles and key features of a system for sharing of individual patient-level data.
- March 2015: MRCT Center hosts collaborative conference with Wellcome Trust to convene stakeholders and create a roadmap that would eventually become Vivli.
- June 2016: MRCT Center outlines the core features of Vivli in a perspective published in the New England Journal of Medicine, laying the foundation for the future global platform.
- March 2017: Vivli incorporated as a non-profit entity with 501(c)(3) status.
- March 2017: Vivli collaborates with Microsoft Health and BlueMetal, an Insight company that specializes in digitally transforming healthcare and life sciences companies into continuously learning health systems.
- October 2017: Former MRCT Center Executive Director Rebecca Li, PhD, is appointed the Executive Director of Vivli, marking its transition from a project within the MRCT Center to a separate and autonomous Center for Global Research Data.
- December 2017: Live demonstration of the Vivli Clinical Trial Data Sharing Platform presented at the MRCT Center’s Annual Meeting.
- July 2018: Public launch of Vivli 1.0
For Updates, please visit: Vivli Platform