The MRCT Center 2018 Annual Meeting was held on December 5, 2018 and convened a diverse group of approximately 80 stakeholders focusing on global clinical trials.
The principal topics discussed at the MRCT Center 2018 Annual Meeting were: (1) European Union General Data Protection Regulation (GDPR), (2) Representation of Diverse Populations, (3) Advancing the Study of Clinical Trials, (4) Capacity Building, and (5) Health Literacy in Clinical Research.
The MRCT Center Bioethics Collaborative is delighted to share a very brief summary of the April 24, 2018 discussion related to Return of Individual Results to Research Participants and Axes of Communication.
The MRCT Center 2016 Annual Meeting was held on December 7, 2016 and was attended by about 80 stakeholders, including representatives from academia, governmental agencies, institutional review boards, the pharmaceutical industry, and non-profit organizations.
The major themes of the MRCT Center 2016 Annual Meeting included the draft ICH E17 guidelines, data sharing and data transparency, and individual return of results (IRR). The draft ICH E17 guidelines, which delineates guidelines for the development of multi-regional clinical trials (MRCTs) for drug development and approval in regulatory authorities around the world were addressed, and a dynamic group discussion followed. Next, data sharing and data transparency were addressed, including the MRCT Center’s work to create Vivli, an independent non-profit center for global research data and invited speakers shared their insights on this pivotal topic. Dr. Murray Stewart (GlaxoSmithKline), the keynote speaker, addressed the current state of data transparency, and the value of global clinical trial data sharing. Finally, the Individual Return of Results (IRR) Working Group presented two major deliverables, the IRR Recommendation Document and IRR Toolkit, and outlined the eight principles the group has drafted. Invited speakers offered their perspectives and suggested revisions on the MRCT Center’s IRR documents.
Proceedings from this meeting are available and presentations are available for sponsors below.
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
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.
MRCT Center at Harvard 2014 Annual Meeting was held on 3 December 2014 and was attended by by more than 60 stakeholders from governmental agencies, pharmaceutical industry, academia, patient advocates, media representatives and others. MRCT Center at Harvard’s Annual Progress Report 2014 was released at the meeting.
The meeting focused on returning aggregate results to research participants. MRCT Center at Harvard faculty co-directors presented drafts of the Return of Results Guidance Document and Toolkit which was followed by perspectives from various stakeholders. In addition, the faculty co-directors gave an overview of MRCT Center at Harvard’s work in India addressing regulatory issues, causality determination, and compensation calculation. Presentations and Proceedings from this meeting are now available
MRCT Center at Harvard collaboratively with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School hosted a one-day open conference on post-trial responsibilities on September 18, 2014, at the Harvard Law School.
The objectives of the conference were to discuss implications of international guidance on post-trial responsibilities for clinical research, to articulate and understand the range of perspectives on post-trial responsibilities, to draw lessons from successful and unsuccessful attempts to implement post-trial policies, and to discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward.
Proceedings are posted for the Clinical Trial Data Sharing and Transparency Conference, co-hosted by the MRCT Center and the Petrie Flom Center of Harvard Law School.
For those in attendance, they will serve as a good reminder of the potential data sharing models developed by four MRCT working groups. For those unable to attend they provide a complete summary of the discussions surrounding clinical trial data sharing and transparency issues, especially timely and relevant to many in academia, industry and government.
