studies and electronic health records, this focus was selected to encourage concrete problem-solving discussions over the course of a day-and-a-half– long meeting. Models and projects that involve sharing of other types of data will be considered during the workshop to the extent that these models provide lessons and best practices applicable to sharing preplanned interventional clinical research data.

The workshop is being jointly organized by the Institute of Medicine’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.

Meeting Objectives:

•   Examine the benefits of sharing of clinical research data, and specifically clinical trial data, from all sectors and among these sectors, including, for example:

o   Benefits to the research and development enterprise

o   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 the identification of priority actions and “low-hanging fruit” opportunities.

•   Discuss strategies for using these potentially large datasets to facilitate scientific and public health advances.

October 4, 2012
Day One

8:30 a.m.

Opening Remarks

SHARON TERRY, Workshop Chair

President and Chief Executive Officer

Genetic Alliance

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