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Global Clinical Trial Data Sharing

Focus Area: Transparency

Global Clinical Trial Data Sharing

As part of its larger Transparency efforts, in 2015 the MRCT Center and a diverse group of global stakeholders embarked on a mission to define, design, and launch a solution to enable global clinical trial data sharing. The solution was envisioned and later embodied as Vivli, a neutral Center for Global Clinical Research Data Sharing as a broker—agnostic to disease, country, sponsor, funder, and investigator— that would establish an independent data repository, analytics platform, and in-depth search engine through which individual participant-level data (IPD) and metadata from clinical trials conducted by researchers in academic, industry, foundation, and non-profit entities could be identified, hosted, shared, and analyzed.Vivli_overview_graphic_5-9If such goals are to be achieved, patient-level data must be readily findable and available for aggregation and analysis amongst multiple sources to enable the widest range of secondary research uses. Current gaps in data hosting, aggregation, and meta-analysis make it difficult to discover which clinical trials’ IPD are available for sharing, however. Vivli offers a complete solution to these current challenges by harmonizing policies and processes for data submission, data request, data access, and sharing of academic credit.

As a non-profit entity, Vivli serves a crucial convening function for biomedical industry, academia, non-profit funders and foundations, government, and patients/ patient advocates. As a platform, Vivli offers a user-friendly, secure, state-of-the-art data sharing and computing environment that serves the international community without bias toward any trial, disease, country, sponsor, funder, or investigator. Additionally, it offers users the ability to discover and combine large clinical trial datasets from disparate sources in a single platform and to access state-of-the-art statistical tools for analysis.

Working with institutional and individual partners, the MRCT Center launched Vivli as an independent Center for Global Research Data in October 2017.

Current Status: Under the Executive Direction of Rebecca Li, Vivli, Inc. is now operating independent of the MRCT Center, functioning as a separate and autonomous Center for Global Clinical Research Data

Impact: Pharmaceutical and biotech industries, academics, and nonprofits may deposit and share clinical trials data seamlessly and effortlessly

Objectives:

  • Promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing enterprise

Key Milestones:

  • September 2015: MRCT Center launches Vivli project; workgroups assembled
  • September 2016: Vivli platform designed; bids solicited from partners
  • March 2017: Vivli gains 501(c)(3) status
  • March 2017: Microsoft and BlueMetal become Vivli’s strategic partners
  • April 2017: Vivli trademark registered and approved by USPTO
  • April 2017: Inaugural Board Meeting of Vivli, inc.
  • June 2017: Vivli platform build commenced
  • September 2017: Vivli’s executive leadership team is assembled
  • March 2018: Vivli Pilot completed; Public Beta Demo underway
  • July 2018: Public launch of Vivli 1.0

Related External Links:

Vivli Platform

A Global, Neutral Platform for Sharing Trial Data