Sharing Clinical Trial Data
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. Four National Academies forums and roundtables, including the Forum on Drug Discovery, Development, and Translation (the Forum), provided momentum and a framework for initiating the IOM consensus study that produced the report, and are supporting coordination and collaboration among stakeholders engaged in data sharing initiatives through the Sharing Clinical Trial Data Collaborative (the Collaborative). The Collaborative engages government, industry, private funders, academia, journals and other sectors to share perspectives, identify priority data sharing issues that require focus and attention, and improve coordination of efforts among key stakeholders.
The Collaborative is an ad hoc activity convened under the auspices of the Forum, in collaboration with the 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 it produces does not necessarily represent the views of any one organization, the Collaborative, the Forum, or the National Academies and is not subjected to the review procedures of, nor is it a report or product of, the National Academies.
Participants in the Action Collaborative are currently undertaking two activities:
- 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.
- Data Sharing Principles for Nonprofit Clinical Trial Funders. Also launched in 2016, this working group is convening nonprofit funders of research, focusing on disease advocacy and patient-focused organizations, to develop standards and policies for fostering, promoting, or requiring data sharing by grantees. This working group of the Collaborative met in July 2016 to discuss principles and strategies for nonprofit funders to share clinical trial data, including associated risks and challenges.