Sharing clinical trial data can facilitate more efficient and effective development of better medicines, diagnostics, and procedures for the ultimate benefit of patients. At the same time, sharing data presents risks, burdens, and challenges that need to be addressed by a broad set of stakeholders. These opportunities and challenges were laid out in the 2015 Institute of Medicine (IOM) report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. The report calls on stakeholders to foster a culture of sharing and offers a blueprint for action within and across sectors. The report makes four overarching recommendations:

1. specific actions key stakeholder groups should take to foster a culture in which data sharing is the expected norm;
2. standards for when to share specific types of data and data packages;
3. operational strategies for how to share data; and,
4. the need for further collaboration among stakeholders with reach, representation, and capability to address remaining key challenges regarding infrastructure, technology, sustainability, workforce, and ethical issues (participant privacy and consent).

Four National Academies’ forums and roundtables, including the Forum on Drug Discovery, Development, and Translation, provided momentum and a framework for initiating the IOM consensus study that produced the report, and supported coordination and collaboration among stakeholders engaged in data sharing initiatives through the Sharing Clinical Trial Data Action Collaborative. The Collaborative engaged government, industry, private funders, academia, journals and other sectors to share perspectives, identify priority issues that require focus and attention, and improve coordination of efforts among key stakeholders.

Collaborative Activities

Participants in the Collaborative undertook the following activities:

• Data Sharing Goals for Nonprofit Funders of Clinical Trials. Launched in 2016, this working group, led by Sharon Terry (Genetic Alliance) and Tim Coetzee (National Multiple Sclerosis Society), convened nonprofit funders of research, focusing on disease advocacy and patient-focused organizations, to develop goals for fostering, promoting, or requiring data sharing by grantees. This working group of the Collaborative met in July 2016 to discuss aspirational goals and strategies for nonprofit funders to share clinical trial data, including associated risks and challenges. The group met again in November 2017 with a larger, broader group of nonprofit organizations and other data sharing stakeholders to review and refine a statement of data sharing goals that could be agreed upon by the participating stakeholders and taken back to organizations’ research boards for incorporation into funding policies. In March 2021, participants published a Viewpoint in the Journal of Participatory Medicine, Data Sharing Goals for Nonprofit Funders of Clinical Trials.
• Building an IT and Technical Infrastructure. A collaboration with Harvard’s Multi Regional Trial Center (MRCT) to convene stakeholders with relevant technical, legal, and content expertise, to define a framework for the key issues in building and sustaining a global technical infrastructure. The working group convened on February 3, 2016, at the National Academies and then released its suggested way forward at a meeting at the Wellcome Trust in London in March 2016. The working group helped inform the IT and technical aspects of the new global data repository – Vivli – publicly launched in July 2018.

The collaborative, which sunset in March 2021, was an ad hoc activity convened under the auspices of the Forum on Drug Discovery, Development, and Translation, Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health at the National Academies of Sciences, Engineering, and Medicine (the National Academies). The work of the collaborative does not necessarily represent the views of any one organization, the Forums or Roundtable, or the National Academies, and was not subjected to the review procedures of, nor was it a report or product of, the National Academies.