On March 30-31st, 2015, over seventy committed international stakeholders joined together at the Harvard Faculty Club in Cambridge Massachusetts to deliberate how to promote and coordinate clinical trials data transparency. Over the two day conference, renowned experts from academia, industry and others shared their organizational experiences in data sharing, distilled best practices, described lessons learned from case studies, reviewed recommendations from the Institute of Medicine report: Strategies for Responsible Sharing of Clinical Trial Data, and considered how best to put those recommendations into practice.
The explicit goal of the conference was to develop an approach whereby:
- Expectations and practices of registration and results reporting of all clinical trials would be regularized among industry and academia;
- Greater access to participants-level clinical trial data could be facilitated using a common portal;
- Researchers would be able to access and combine data across various platforms and sponsors, to multiply opportunities for data analysis; and
- Research participant privacy can be safeguarded
- The assembled participants separated into four parallel break-out sessions to discuss lessons learned in their ongoing data sharing initiatives and to consider options for promoting clinical trials data sharing and bringing consistency to data sharing efforts. The data sharing models that emerged from these discussions shared similar characteristics including:
Organizational structure – A centralized, international, not-for-profit organization responsible for a coordinated data sharing initiative;
- A centralized and single portal – A central user interface with a robust search engine functionality, including information on trials around the world, with the capability to grow and add data from new sponsors;
- Governance – Creation of an empowered central multi-stakeholder body with authority and accountability to enable the long term vision wherein a not-for-profit entity may promote and oversee the data sharing enterprise end-to-end;
- Data requirements – Sufficient data pedigree including, data definition and metadata to enable the appropriate integration of datasets across studies and sponsors for analysis;
- Shared or common services – Efficient shared or common services across data generators / sponsors (policy setting, data de-identification, and when appropriate, criteria for independent review panel decisions); and
- Flexibility – A data platform that accommodates differing expectations and research needs, including the ability to download data if freely available and the ability to host data for those data generators that do not wish to do so themselves.
Consensus in three primary action areas was identified, with a goal of working toward implementation over the next 18 months. These areas encompass:
- The creation of a working group tasked with development of specific principles, operating guidelines, and characteristics of the suggested not-for-profit organization and its governance. The goal of the not-for-profit organization would be to oversee, create, implement and direct a sustainable data-sharing platform. Initially this working group will be led by MRCT Center at Harvard and the Wellcome Trust, with active participation from the John and Laura Arnold Foundation.
- The results and recommendations of the working group would be reviewed and commented upon by a variety of public and private stakeholders, not limited to the participants in the March 2015 Harvard meeting. Discussions and follow-up will be expanded to include the perspectives of trial registries, start-up companies, university leaders, public sponsors, disease foundations and medical journals.
- Policy initiatives and a communication plan will be created to promote and incentivize clinical trials data sharing. This will potentially include journal publishing requirements, academic and faculty acknowledgements of contributions relevant for promotions, and others, to promote practices of open data in the academic setting.
The participants of the data-sharing workshop demonstrated their personal commitments to data transparency and agreed that progress toward a sustainable solution may be challenging but is an important transformative goal.
This conference, which followed from an earlier multi-stakeholder conference held at Harvard in May 2013, was supported and hosted by The MRCT Center at Harvard, the Laura and John Arnold Foundation, and the Wellcome Trust.
Conference Proceedings have been released and pre-conference survey results.