January 14, 2015

Statement on the Institute of Medicine Report on Sharing Clinical Trial Data

I want to thank the Institute of Medicine (IOM) for its important and thoughtful report, Sharing Clinical Trial Data – Maximizing Benefits, Minimizing Risk, which was commissioned by NIH and a number of other sponsors. Data sharing is fundamental to NIH’s mission, and the responsible sharing of clinical trials data in ways that protects patient privacy has many important benefits. Through responsible data sharing, participants in clinical trials are assured that their contributions to research will have maximal effect, and researchers are able to accelerate efforts to prevent, detect, and treat disease by validating and advancing results. Data sharing also improves the efficiency of clinical research and bolsters safety in clinical trials by preventing unnecessary duplication of trials, including trials of products that have already been found to be unsafe or ineffective.  NIH is committed to advancing efforts in this arena, and the IOM report presents thoughtful analysis and useful points to consider about how to promote responsible access to participant level data.

The IOM report is timely, coming on the heels of two important measures taken by the Department of Health and Human Services and NIH to enhance transparency in clinical trials. The first is a proposed rule that clarifies the requirements under the Food and Drug Administration Amendments Act of 2007 (FDAAA) for clinical trial researchers to register and to submit summary-level trial results information to ClinicalTrials.gov for specified trials of FDA-approved drugs and devices. The proposed rule would also expand the results submission requirement to trials of unapproved products. The second is a complementary draft NIH policy that expects all NIH-funded clinical trials, whether or not they are subject to FDAAA, to submit the same registration and summary results information as specified in the proposed rule. We look forward to hearing from the community on these two proposals. The feedback will be critically important as we consider the IOM report and NIH’s role in enhancing the responsible sharing of data from clinical trials for the benefit of all.

Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health