评估基于注册表的试验经济学:来自STRESS临床试验的结果
Eric L Eisenstein1, Kevin D Hill1,2, Nancy Wood1
1Duke Clinical Research Institute, Durham, NC, USA.
Contemporary clinical trials communications
|February 1, 2024
概括
基于注册表的随机临床试验 (RCT) 比实用和解释性RCT设计更具成本效益. 虽然基于注册表的RCT可以大大节省成本,但由于数据收集,它们可能会增加试验持续时间.
科学领域:
- 临床试验方法论 临床试验方法论
- 医疗保健服务研究 医疗服务研究
- 生物统计学 生物统计学
背景情况:
- 与传统的随机临床试验 (RCT) 相比,基于注册表的试验提供了潜在的成本降低.
- 实用性试验设计也可以实现成本效益.
- 在基于注册表的实用和解释性RCT设计中,试验成本的直接比较尚未系统地进行.
研究的目的:
- 系统地比较基于注册表的RCT的总成本,持续时间和人员工作时间与实用和解释性的RCT设计.
- 通过使用不同的设计方法来评估降低婴儿心脏手术后系统性炎症的类固醇 (STRESS) 试验的成本效益.
主要方法:
- 该研究比较了婴儿心脏手术后降低系统性炎症的类固醇 (STRESS) 基于注册表的RCT与两个既定的设计:实用RCT和解释性RCT.
- 主要结果是总的RCT设计成本,估计使用杜克临床研究院的定价模型.
- 其次要结果包括RCT持续时间和人员工作时间.
主要成果:
- 基于注册表的RCT的估计持续时间比其他设计长31.9周,归因于定期收集数据延迟网站关闭和报告.
- 解释性设计 (52,488小时) 的员工总工作时间最多,其次是实用性 (29,763小时) 和基于注册表的 (24,480小时).
- 解释性设计 (10,140,263美元) 的总成本最高,其次是实用性设计 (4,164,863美元) 和基于注册表的 (3268,504美元),基于注册表的成本为解释性设计的32%,实用性设计的78%.
结论:
- 基于注册表的RCT比实用和解释性设计具有显著的成本优势,正如STRESS试验所证明的那样.
- 通过利用注册表资源和特定设计元素来实现成本节约,从而提高成本效益.
- 必须仔细考虑和管理与基于注册表的设计相关的试验完成的潜在延迟.
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