The Institute of Medicine (IOM) Jan. 14 released a report titled, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk,” in an effort to establish guiding principles and a practical framework for the responsible sharing of clinical trial data.
The report highlights the critical role of data sharing in increasing scientific knowledge and leading to better therapies for patients, while also examining the risks, burdens, and challenges inherent in sharing data from clinical trials.
The report recommends that findings from clinical trials should be released within 18 months of trial completion, with exceptions for data that are part of a submission to a regulatory agency for approval. However, the report also notes that data from trials with significant public health, clinical, or policy implications may need to be shared sooner than 18 months. Barriers to sharing include the lack of proper infrastructure, searchable and interoperable data platforms, an adequate workforce, and distribution of costs to create a sustainable system of data sharing.
The report encourages the sharing of best practices within the research community and a culture that promotes data sharing, while emphasizing the roles of different stakeholders in facilitating data sharing. Specifically, it concludes that research institutions and universities can influence data sharing activities by providing:
- infrastructure support in the areas of data curation, archiving, and sharing;
- incentives in performance review and promotion;
- additional training in clinical research education on procedures and structures needed to share data; and
- assessment of data sharing plans in any internal scientific review.
The study was commissioned by 23 public- and private-sector sponsors, including the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and numerous pharmaceutical companies, and was chaired by Bernard Lo, M.D., president of the Greenwall Foundation.
In a Jan. 14 statement, NIH Director Francis Collins, M.D., Ph.D. acknowledged the importance of the report and its timely release, given the current push by the Department of Health and Human Services and NIH to enhance transparency in clinical trials. “Data sharing,” Dr. Collins said, “is fundamental to NIH’s mission and the responsible sharing of clinical trials data in ways that protect patient privacy has many important benefits.”