包括临床试验中的患者和公众贡献者 独立数据监测委员会 (IDMCs)
Elizabeth Allaway1, Irene Soulsby2, Nicole Keyworth3
1Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK. L.Allaway@soton.ac.uk.
Trials
|February 18, 2026
概括
公共贡献者可以有意义地参与独立数据监测委员会 (IDMCs) 进行适当培训. 这项研究开发和完善了资源,以支持公众参与复杂的临床试验监督会议.
科学领域:
- 临床试验方法论 临床试验方法论
- 患者和公众参与 (PPI)
- 医疗保健服务研究 医疗服务研究
背景情况:
- 患者与公众参与 (PPI) 是在英国临床试验中建立的,但很少包括独立数据监测委员会 (IDMC).
- 关于如何有效地将公众纳入IDMC会议以及PPI的潜在影响的证据有限.
- 南安普顿临床试验单位 (SCTU) 与IDMC协调了许多癌症药物试验,并试图整合PPI.
研究的目的:
- 建立一个可行的过程,包括公共贡献者在IDMCs.
- 评估参与IDMCs的公共贡献者的培训和资源需求.
- 为其他人提供关于为试验IDMCs开发类似PPI倡议的信息.
主要方法:
- 采用基于设计和行动研究的方法来开发初级培训.
- 在SCTU癌症试验中进行了培训,收集了公众贡献者,试验人员,首席调查员和IDMC主席的反.
- 根据反改进了培训计划,并在三个额外的试验中进一步评估了它.
主要成果:
- 开发的培训被发现对公共贡献者来说是有用和有信息的.
- 公共贡献者能够有意义地为IDMC会议做出贡献.
- 反促进了流程的改进,以便在SCTU试验中更广泛地实施.
结论:
- 为IDMC的公共贡献者开发,审查和完善培训材料和资源.
- 公共贡献者,试验团队和IDMC主席的反在很大程度上是积极的.
- 将公众参与者纳入IDMC是可行的,如果提供足够的培训和资源,可以加强委员会的工作.
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