Focus Area: Quality & Transparency

Proceedings available from The Future of Clinical Trials Data Sharing Conference

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

Conference proceedings have been released and are available for MRCT sponsors.

Wellcome-Conference-Proceedings-18-April-20161 (1)Download

Conference on the Future of Data Sharing

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.

For the final agenda of the meeting, Click Here.

To learn more about the MRCT Center’s Data Sharing and Transparency Initiative, Click Here.

Data Sharing

Proceedings, Presentations and Annual Report Available from MRCT Center’s 2015 Annual Meeting

The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.

The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency. The Post-Trial Responsibilities (PTR) Working Group developed an Ethics Framework with two main deliverables: a PTR Guidance Document and a PTR Toolkit. Invited speakers shared their perspectives and suggestions for revisions. The Data Sharing and Data Transparency Initiative’s current progress on developing a blueprint for a new, not-for-profit entity was presented. Invited speakers shared their perspectives on the project vision to date.

Proceedings from this meeting are now available. Presentations from the Post-Trial Responsibilities working group and from the Data Sharing and Data Transparency Initiative are available for sponsors.

MRCT Center wins the 2015 Award for Excellence in Human Research Protection

The 2015 Awards for Excellence in Human Research Protection were announced on December 28th by Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute, “The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard won the 2015 Annual Award for Best Practice for the MRCT Return of Results Guidance Document and MRCT Return of Results Toolkit.

This toolkit and guidance document provides guidance and examples for disseminating non-technical summaries to participants of clinical trials, and have been used in Europe to draft equivalent materials for both the EU and UK. These materials are currently being adapted for use in South Korea for non-Western and integrative medicine.