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规划适应性平台试验的关键考虑:第1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.

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概括
此摘要是机器生成的。

适应性平台试验 (APT) 在临床研究中提供了灵活性和效率,但计划起来很复杂. 本指南为设计这些复杂的随机临床试验的研究人员提供了必要的考虑因素.

关键词:
适应性平台的试验试验.这是指导的指导,指导的指导.方法 方法 方法 方法.利益相关者参与 利益相关者参与试验设计试验设计.

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科学领域:

  • 临床试验方法论 临床试验方法论
  • 适应性试验设计

背景情况:

  • 对复杂临床研究的适应性平台试验 (APT) 越来越感兴趣.
  • 与传统试验相比,APT提供了更高的灵活性,效率和成本效益.
  • 目前对于计划APT的指导是有限的.

研究的目的:

  • 为适应性平台试验提供关键规划考虑因素的叙事概述.
  • 提供基于APT启动的实践经验的指导.

主要方法:

  • 这是一个分为两部分的系列,详细介绍了APT的基本规划方面.
  • 专注于对关键考虑的叙事概述.

主要成果:

  • 第一部分涵盖了利益相关者的参与,人口,干预,结果和适应.
  • 第二部分将讨论统计,设计特征,数据,操作,资金,传播和实施.

结论:

  • 本指南旨在协助研究人员规划适应性平台试验.
  • 提出了关键考虑因素,以促进APT的成功设计和启动.