present challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets.

Despite these barriers, there is increasing acknowledgment among researchers of the importance and potential benefits to sharing clinical research data at various stages of the research, discovery, and development pipeline. Precompetitive collaboration models promote the sharing of resources and risk among competitors at early stages of the research process, with the goal of providing benefit to all parties. A number of collaborations, including public-private partnerships, have formed to overcome these barriers in order to advance clinical research and accelerate the discovery and development of therapeutics and diagnostic tools.

On October 4-5, 2012, four groups within the Institute of Medicine—the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Translating Genomic-Based Research for Health—collectively hosted a workshop to examine and advance this pressing issue. The workshop explored the benefits of sharing clinical research data, the barriers to such sharing, and strategies to address these barriers to facilitate the development of safe, effective therapeutics and diagnostics. Box 1-1 provides the objectives of the workshop. The workshop was designed to provide a neutral venue where stakeholders from government, academia, industry, foundations, public-private partnerships, patient groups, and the public could meet to discuss issues of mutual interest. It is part of a larger effort to build partnerships and enhance collaboration within and among sectors on research, development, and assessment of pharmaceutical products. While acknowledging the importance of other kinds of clinical data, the workshop organizers focused on issues relating to sharing of data from preplanned interventional studies of human subjects. This summary of the workshop presents the observations, viewpoints, and suggestions made during both the presentations and discussion sessions as a way of informing the public, the press, and policy makers about the major issues surrounding the sharing of clinical research data.

ORGANIZATION OF THE REPORT

In the final session of the workshop, the moderators of each workshop session identified the major points that emerged during their sessions



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