Responsible sharing of clinical trial data is widely recognized as serving the public interest. Data sharing helps maximize the contributions to scientific knowledge made by clinical trial participants – benefiting patients today and in the future. Clinical trial data sharing can enable reproducibility of research findings, analyses for other areas of study; and exploratory work to generate new research hypotheses. While progress has been made in the endeavor of improving clinical trial data sharing, challenges still remain.
On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop, in Washington, DC, titled “Sharing Clinical Trial Data: Challenges and a Way Forward.” The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse since the report release. The workshop considered ways in which policy, technology, incentives, and governance could be leveraged to overcome remaining barriers and further facilitate data sharing.
Co-sponsored by the Wellcome Trust, the workshop was jointly convened by the National Academies Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health.
A presentation of the recommendations from the 2015 IOM Consensus Study, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, set the stage for workshop discussions and established a reference point for identifying new progress and barriers in data sharing since the report’s release:
Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.
Sponsors and investigators should share the various types of clinical trial data no later than the times specified in this report (e.g., the full analyzable dataset with metadata no later than 18 months after study completion—with specified exceptions for trials intended to support a regulatory application—and the analytic dataset supporting publication results no later than 6 months after publication).
Holders of clinical trial data should mitigate the risks and enhance the benefits of sharing sensitive clinical trial data by implementing operational strategies that include employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent.
The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multistakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data.
Workshop participants considered the current landscape for clinical trial data sharing and reuse, and shared perspectives on current data sharing policies in practice.
Workshop participants presented four examples of clinical trial data sharing repositories, including the Vivli platform, Yale University Open Data Access (YODA), Supporting Open Access for Researchers (SOAR), and ClinicalStudyDataRequest.com (CSDR).
Workshop participants offered perspectives on balancing the value and benefits of sharing data with the risks and costs.
Workshop participants considered key barriers to data interoperability and platform usability based on three case examples: 1) population data from cancer prevention trials; 2) individual participant data (IPD) network meta-analysis; and 3) open-access data sharing models.
Workshop participants discussed infrastructure sustainability challenges as key barriers to clinical trial data sharing and reuse.
Workshop participants examined challenges and disincentives for sharing and reusing data.
Workshop participants explored opportunities and potential solutions for overcoming the technical and sustainability challenges identified throughout the workshop.
Workshop participants considered steps needed to incentivize and promote data sharing and reuse.