规划适应性平台试验的关键考虑:第二部分
Anders Granholm1, Morten Hylander Møller2, Aldana Rosso3
1Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark; Platform Trial Unit, Value and Coherence, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark; Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Journal of clinical epidemiology
|March 9, 2026
概括
适应性平台试验 (APT) 在临床研究中提供了灵活性和效率,但需要仔细规划. 本指南详细介绍了有效设计和实施复杂APT的关键考虑因素.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 适应性平台试验 (APT) 是复杂,灵活和高效的随机临床试验 (RCT).
- APT允许在核心协议中不断添加干预措施,从而实现永久运行.
- 尽管有好处,但由于可用的指南有限,规划APT存在挑战.
研究的目的:
- 为规划适应性平台试验提供关键考虑因素的叙事概述.
- 提供基于计划和启动APT的实际经验的指导.
- 支持研究人员在设计和实施APT的复杂过程中.
主要方法:
- 这是关于APT规划的两部分系列的第二部分.
- 该系列提供了对基本规划考虑的叙事概述.
- 专注于APT的统计,运营和后勤方面.
主要成果:
- 第一部分涉及利益相关者的参与,人口,干预措施,结果和适应.
- 本部分详细介绍了统计,设计特征,数据基础设施,运营,资金,传播和实施方面的考虑.
- 这里列出了APT规划的7个关键考虑因素的综合清单.
结论:
- 提供的指南旨在帮助研究人员规划适应性平台试验.
- 有效的规划对于APT的成功实施至关重要.
- 本系列为APT设计和执行的有限知识提供了贡献.
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