Strategies for the Responsible Sharing of Clinical Trial Data: Guiding Principles and a Framework for Implementation

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Project Summary Over the course of 17 months, the committee will hold five meetings as well as at least one public workshop that involves international participants. At least two of these meetings will allocate time for public comment to be received. The committee will also identify other avenues for receiving input from interested stakeholders. Nominations for the study committee will be sought from a variety of sources, including NIH, FDA, other relevant federal agencies, the IOM and NAS membership, relevant IOM Boards and Roundtables, academic institutions, professional associations, patient and family groups, and other expert and stakeholder groups. Care will be taken to ensure that the committee is balanced and has the necessary research, policy, and work experience. The work of committee members and staff may be supplemented by consultants to provide additional expertise, for example, through the preparation of background papers. The first committee meeting will be a four-day meeting. It will include a critical examination of the charge to the committee through in-depth discussion with the project sponsors about the tasks and existing data sharing activities, as well as planning of a public workshop to be held in conjunction with the second meeting. The committee will also create a framework for discussion that will be subject to institutional review procedures prior to its release, which is planned for January 2014.The framework for discussion will be released for public comment to stimulate comments and input from the public that could inform the committee's deliberations. The second meeting will include the conduct of a public workshop to obtain public input on the framework for discussion and generally on issues within the scope of the committee's charge. The third and fourth meetings will be used to develop and refine draft report findings and to organize the writing of the report; the third meeting will also include the conduct of a second public workshop to obtain public input to the committee on the analysis and governance of the selected data sharing activities. The fifth meeting will be used to reach final agreement on the committee findings, recommendations, and the preparation of the draft report for review. The report will be subject to institutional review procedures prior to release. A prepublication copy of the report is expected to be delivered to the sponsors after 17 months following the start of the project.