Sharing and reuse of individual participant data from clinical trials: principles and recommendations
Sharing and reuse of individual participant data from clinical trials: principles and recommendations
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DOI：
10.1136/bmjopen-2017-018647
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发表时间：
2017-12-01
期刊：
影响因子：
2.9
通讯作者：
Demotes-Mainard, Jacques
中科院分区：
文献类型：
--
作者：
Ohmann, Christian;Banzi, Rita;Demotes-Mainard, Jacques
目标 我们研究了与共享个体临床试验数据相关的主要问题，并使用广泛的跨学科方法制定了一份关于提供临床试验个体参与者数据访问的共识文件。设计和方法这是多利益相关方工作组成员之间达成共识的过程，涉及广泛的专家（研究人员、患者代表、方法学家、信息技术专家以及资助者、基础设施和标准制定组织的代表）。一位独立协调人使用名义组技术支持该过程。 The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed.这项工作是在地平线 2020 资助的 CORBEL 项目（构建持久生命科学服务的协调研究基础设施）中进行的，并由欧洲临床研究基础设施网络进行协调。因此，重点是非商业试验，视角主要是欧洲。 结果 我们就如何共享临床试验数据制定了原则和实用建议。 结果 特别工作组就 10 项原则和 50 项建议达成共识，代表了用于共享临床试验数据的任何框架的基本要求。该文件涵盖以下主要领域：使数据共享成为现实（例如，文化变革、学术激励、资助）、数据共享同意、保护试验参与者（例如，去身份化）、数据标准、权利、访问类型和管理（例如，数据请求和访问模型）、数据管理和存储库、可发现性和元数据。 结论 采用本文件中的建议将有助于促进和支持研究人员之间的数据共享和重用，充分告知试验参与者并保护他们的权利，并提供有效和高效的系统 for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice.需要开展进一步的工作，将这些提案与其他地理区域和其他学术领域的提案整合起来。
Objectives We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach.Design and methods This was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European.Outcome We developed principles and practical recommendations on how to share data from clinical trials.Results The task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata.Conclusions The adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.