Strategies for the Responsible Sharing of Clinical Trial Data: Guiding Principles and a Framework for Implementation
负责任地共享临床试验数据的策略:指导原则和实施框架
基本信息
- 批准号:8839023
- 负责人:
- 金额:$ 2.5万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-09-12 至 2015-08-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
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.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Anne B Claiborne其他文献
Anne B Claiborne的其他文献
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{{ truncateString('Anne B Claiborne', 18)}}的其他基金
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
药物发现、开发和转化论坛
- 批准号:
9091015 - 财政年份:2015
- 资助金额:
$ 2.5万 - 项目类别:
Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceuticals: An IOM Workshop
描述和传达药品效益和风险评估中的不确定性:IOM 研讨会
- 批准号:
8996009 - 财政年份:2015
- 资助金额:
$ 2.5万 - 项目类别:
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
药物发现、开发和转化论坛
- 批准号:
8838373 - 财政年份:2014
- 资助金额:
$ 2.5万 - 项目类别:
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