临床试验的新试验监测计划 (TMP) 模板:来自Delphi过程的输出
Shiva Taheri1, Victoria Yorke-Edwards2,3, Matthew R Sydes4,5
1MRC Clinical Trials Unit at UCL, 90 High Holborn, London, WC1V 6LJ, UK. s.taheri@ucl.ac.uk.
Trials
|November 8, 2024
概括
使用专家投入和Delphi调查开发了一个新的临床试验监测计划 (TMP) 模板,以标准化临床试验监测. 这确保了一致的,高质量的研究,并保护了参与者的权利和数据完整性.
科学领域:
- 临床研究 临床研究
- 试验管理试验管理
- 质量保证 质量保证 质量保证
背景情况:
- 有效的临床试验监测对于数据完整性和参与者保护至关重要.
- 改善当前的监测实践需要标准化的工具和专家的共识.
- 本研究解决了需要一个强大的试验监测计划 (TMP) 模板的需求.
研究的目的:
- 开发一个标准化的试验监测计划 (TMP) 模板.
- 纳入专家经验和临床试验监测专业人员的共识.
- 提高临床试验监测的质量和一致性.
主要方法:
- 从英国临床研究协作 (UKCRC) 注册的临床试验单位 (CTU) 的现有计划中创建了一个初步的TMP模板.
- 进行了两轮的Delphi调查,涉及来自英国25个CTU和行业的47名参与者.
- 一次共识会议,由来自英国9个工会和行业的9名参与者组成,最终确定了TMP模板.
主要成果:
- 审查了31个监测计划,并根据良好的临床实践 (GCP) 和专家经验评估了800多个项目.
- 德尔菲调查完善了TMP模板,在第二轮调查中达成共识的项目有37个.
- 一次共识会议最终确定了模板,最终由众多监测专家提供了标准化的TMP.
结论:
- 通过严格的共识过程,成功开发了一个全面的TMP模板.
- 标准化的TMP旨在确保CTU之间一致的监测标准,提高研究质量.
- 使用TMP模板将提高质量保证和参与者对数据保护和道德处理的信心.
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