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Global Clinical Trial Data Sharing

Focus Area: Data Transparency

Global Clinical Trial Data Sharing

Clinical trials conducted to determine the safety and efficacy of biomedical interventions generate vast amounts of individual participant-level data (IPD) and metadata. These data not only inform clinical and regulatory decision-making, but can also be shared and made available to additional investigators for a variety of secondary research uses. Secondary research uses of clinical trials IPD and metadata permit verification of the original results, facilitate other critical secondary research (e.g., evaluation of adverse event rates, identification of surrogate end points), prevent unnecessary and potentially risky duplicative trials, and promote public trust through transparency.

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If 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. However, it is currently difficult to discover which clinical trials’ IPD are available for sharing. Moreover, a limited range of analytical tools are available to perform secondary analyses. Even if researchers wish to share their data, there is no turnkey solution to hosting data—a problem that is particularly acute for academic researchers.

Working with institutional and individual partners, the MRCT Center launched the non-profit entity Vivli as an independent Center for Global Research Data. Vivli links existing data-sharing platforms and communities while hosting data from investigators and entities who aspire to share data but lack the resources to do so. The goal of Vivli is to create, direct, implement, and oversee a sustainable data sharing platform to enhance scientific discovery. Vivli serves a crucial convening function: it harmonizes language and agreements amongst stakeholders from industry, academia, non-profit, government, and patient/patient advocacy groups to advance the culture of data sharing. 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. Vivli 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.

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 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

Related External Links:

Vivli Platform

A Global, Neutral Platform for Sharing Trial Data