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与参与者分享临床试验结果:重要、必要且可行。

Sharing clinical trial results with participants: important, expected and possible.

作者信息

South Annabelle, Bale Claire, Chowdhury Enhad, Churchill Alexander, Donoghue Kim, Grieveson Simon, Hartley Charlotte, Manville Catriona, Polanco Angela, Prior Kieran, Scales Sheona, Shearman Kirstie, Parmar Mahesh K B

机构信息

MRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.

Parkinson's UK, London, UK.

出版信息

Trials. 2025 Mar 27;26(1):107. doi: 10.1186/s13063-025-08802-0.

Abstract

Participants in clinical trials should be pro-actively offered the results of trials in which they have participated. This should be done in a way that is accessible and understandable for all participants. People who have taken part in research have a right to know the results of the studies in which they have taken part and should be given the option of receiving these results. Most trial participants want to receive the overall results. Key reasons for sharing results include respecting participants' contributions, enhancing their understanding of research benefits, increasing transparency, and potentially improving recruitment and retention. We propose 8 principles to guide sharing of results with trial participants:1. Trial teams should pro-actively offer overall study results to all clinical trial participants, irrespective of what the results show.2. Participants should be given the choice of whether to receive research results.3. Results should be offered to participants in a timely manner.4. Trial teams should manage participants' expectations around when the results will be available.5. Results should be offered in a way that is accessible to participants, both in terms of the communication mechanism and the content.6. Patient and public involvement is essential in sharing results with participants.7. Sharing results with participants requires resources.8. Consideration needs to be given to potential barriers/challenges to sharing results with participants from the planning stage of the study.

摘要

临床试验的参与者应被主动提供他们所参与试验的结果。应以所有参与者都能获取并理解的方式来进行这一操作。参与研究的人有权知晓他们所参与研究的结果,并且应被给予接收这些结果的选择权。大多数试验参与者都希望收到总体结果。分享结果的主要原因包括尊重参与者的贡献、增强他们对研究益处的理解、提高透明度以及可能改善招募和留存情况。我们提出8项原则来指导与试验参与者分享结果:1. 试验团队应主动向所有临床试验参与者提供总体研究结果,无论结果如何。2. 应给予参与者选择是否接收研究结果的权利。3. 应及时向参与者提供结果。4. 试验团队应管理参与者对结果何时可得的预期。5. 应以参与者能够获取的方式提供结果,包括沟通机制和内容方面。6. 患者和公众参与对于与参与者分享结果至关重要。7. 与参与者分享结果需要资源。8. 从研究规划阶段开始就需要考虑与参与者分享结果时可能存在的障碍/挑战。

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