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

项目摘要 在17个月的时间里，委员会将举行五次会议和至少一次会议 有国际参与者参加的公共讲习班。其中至少有两次会议将 为收到公众意见分配时间。该委员会还将确定其他途径 用于从感兴趣的利益相关者那里获得意见。研究委员会的提名名单如下 从各种来源寻求，包括NIH、FDA、其他相关联邦机构、国际移民组织 和NAS成员、有关的国际移民组织理事会和圆桌会议、学术机构、 专业协会、患者和家庭团体以及其他专家和利益相关者团体。 将注意确保委员会保持平衡，并进行必要的研究， 政策和工作经验。委员会成员和工作人员的工作可以补充 由顾问提供额外的专门知识，例如通过编制 背景文件。 第一次委员会会议将是为期四天的会议。它将包括对 通过与项目赞助商深入讨论 任务和现有数据共享活动，以及计划在#年举办一次公共讲习班 与第二次会议联系起来。该委员会还将创建一个讨论框架 它将在发布前接受机构审查程序，计划于 2014年1月将发布讨论框架，征求公众意见，以激发 来自公众的评论和意见，可以为委员会的审议提供信息。第二 会议将包括举办一次公开讲习班，以征求公众对以下框架的意见 讨论和一般地讨论委员会负责范围内的问题。第三和 第四次会议将用于拟定和完善报告结论草稿，并组织 编写报告；第三次会议还将包括举办第二次公开讲习班 就选定数据的分析和治理向委员会征求公众意见 分享活动。第五次会议将用于就委员会达成最终协议 调查结果、建议和编写供审查的报告草稿。这份报告将是 在发布之前要经过机构审查程序。报告出版前的副本是 预计在项目开始后17个月后交付给赞助商。

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.