In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field.
These documents have been revised, and the latest versions are now available:
The MRCT Center spearheaded a Perspective in the New England Journal of Medicine that spells out the need and requirements for a global, neutral platform for sharing clinical trial data.
While sharing clinical data is critical to inform clinical and regulatory decision making and to honor trial participants who put themselves at risk, most data generators have no formal mechanism or easily accessible platform for sharing their data, and there has been no organized effort to date to coordinate existing platforms to enable most data generators to share their trial data.
The MRCT Center, working with partners, is currently designing a platform called “Vivli” that will link existing data-sharing platforms and communities while hosting data from investigators who aspire to share their data. Vivli will offer a global, neutral platform to host data securely, with search and data-request services, and will allow for combining of data sets from multiple clinical trials.
A central objective of this global data sharing platform is wide cooperation and collaboration, through inclusion of trials funded and conducted by academia, government, industry, and non-governmental organizations which requires shared governance. Therefore, a wide representation from diverse communities and countries as well as trial participants is needed, and data generators now using other data-sharing platforms will participate in governance.
Read more about the Perspective in the New England Journal of Medicine
The MRCT Center, in collaboration with The Wellcome Trust, held a conference on “The Future of Clinical Trials Data Sharing” in London, U.K., March 21-22, 2016 with approximately 100 participants from academia, government, not-for-profit organizations, journal editors and industry.
The main theme of the conference was the presentation of plans for Vivli, a new entity for global data sharing that was developed by the Governance, Business Models, and Data Sharing Platform Workgroups which had been formed subsequent to last year’s data transparency conference.
Vivli is adapted from the Greek word for library, ‘vivliothiki’ and the Latin root ‘viv’ for life. The hope is that Vivli “the library of life” will evoke cooperation, collaboration and a determination to respect the altruism of clinical trial participants worldwide for the benefit of medicine and public health.
The mission of Vivli is to promote, coordinate, and facilitate clinical research data sharing through the creation and implementation of a sustainable global data-sharing enterprise that will:
Protect study participants’ privacy and respect the legitimate interests of data generators, funders and sponsors
Encompass the full breadth of clinical trials funded and conducted by academia, government, industry and others
Respect and bridge to or incorporate existing data sharing platforms
Provide the capability to host and analyze data, as well as to enable discovery of data on external or generator platforms.
Interact with and complement current registries, results reporting platforms, and regulatory initiatives
Provide an independent review process for data requests, where required
Develop global, fair data sharing policies and practices
Experts in data sharing and conference participants responded to the plans for the new entity. Consensus recommendations for Vivli included:
Strengthen the Vivli value proposition to ensure that the Vivli initiative will address a clear gap
Accelerate the timeline to create Vivli and to launch a pilot program
Respect existing platforms and take the existing efforts into account when developing the Vivli platform
On March 21-22, 2016 at an invitation-only meeting at the Wellcome Trust in London, the MRCT Center and collaborators shared plans to launch a new not-for-profit organization, Vivli, charged with directing, implementing and governing a global clinical trial data-sharing platform. The plans for an approach whereby data from multiple sources can be integrated, enabling researchers to access and combine data across various platforms were deliberated.
The approximately 100 participants–including members from academia, government, not for profit, journal editors and industry–provided essential feedback on the proposed strategic path forward and the potential implementable solutions. Conference proceedings will be available shortly.
