Sharing Clinical Research Data: A Workshop

When: October 4, 2012 - October 5, 2012 (8:30 AM Eastern)
Where: National Academy of Sciences Building (Room 125) • 2101 Constitution Avenue, NW, Washington, DC 20418

Topics Biomedical and Health Research, Public Health
Activities: Sharing Clinical Research Data: A Workshop, Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum
Boards: Board on Health Care Services, Board on Health Sciences Policy

Pharmaceutical companies, academics, and government agencies such as the Food and Drug Administration and the National Institutes of Health have large quantities of clinical research data. Data sharing within each sector and across sectors could facilitate scientific and public health advances and could enhance analysis of safety and efficacy. Much of this information, however, is never published. This workshop explored barriers to sharing of clinical research data, specifically clinical trial data, and strategies for enhancing sharing within sectors and among sectors to facilitate research and development of effective, safe, and needed products.

A number of efforts are currently underway to enhance public/private partnerships and foster collaboration within the pharmaceutical sector to advance research and enhance the discovery and development of drugs, devices, and diagnostic tools. Examples include the Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative; the Foundation for the National Institute of Health’s Biomarkers Consortium; the Innovative Medicines Initiative (Europe); Critical Path Institute; Sage Bionetworks’ Clinical Trial Comparator Arm Partnership; and the Life Sciences Consortium’s MetaPharm project. Planned within the context of these various efforts, this workshop focused specifically on data sharing, which is one component of larger efforts to build partnerships and enhance collaboration within and among sectors on research, development, and assessment of pharmaceutical products.

This project was a coordinated effort of the IOM's Forum on Drug Discovery, Development and Translation; Forum on Neuroscience and Nervous System Disorders; National Cancer Policy Forum; and Roundtable on Translating Genomic-Based Research for Health. All four Forums/Roundtables have done previous work on this topic and this issue cuts across the focus of each activity.

The Institute of Medicine conducted a public workshop that focused on strategies to facilitate sharing of clinical research data. Participants were invited from industry, academia, government agencies such as FDA and NIH, disease advocacy groups, and other stakeholder groups. The workshop featured invited presentations and discussions that had:

• Examine the benefits of sharing of clinical research data from all sectors and among these sectors, including benefits to the research and development enterprise and benefits to the analysis of safety and efficacy; 
• Identify barriers and challenges to sharing clinical research data;
• Explore strategies to address these barriers and challenges, including identifying priority actions and “low-hanging fruit” opportunities; and
• Discuss strategies for using these potentially large data sets to facilitate scientific and public health advances.

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