医疗器械随机对照试验与自适应设计的特征
Gui Su1, Dan Shen2, Dongyuan Deng1
1Department of Clinical Research & Medical Science, Medtronic China, 22nd Floor, Block D, The Place Tower, No. 9 Guanghua Road, Chaoyang District, Beijing, 100020, China.
Journal of comparative effectiveness research
|December 10, 2024
概括
医疗器械临床试验中的自适应设计正在减少,其中组序列设计和样本大小重新评估是最常见的. 这项研究描述了它们的使用和随着时间的推移的趋势.
科学领域:
- 临床试验方法论 临床试验方法论
- 医疗器械研究 医疗器械研究
- 生物统计学 生物统计学
背景情况:
- 适应性设计在药物随机对照试验 (RCT) 中很常见,但它们在医疗器械RCT中的应用理解较少.
- 在医疗器械RCT中描述适应性设计的使用对于理解试验方法和趋势至关重要.
研究的目的:
- 描述医疗器械随机对照试验 (RCT),利用适应性设计.
- 分析适应性医疗器械RCT的趋势和共同特征.
主要方法:
- 在2000年1月至2024年10月期间,搜索了临床试验.gov,ICTRP和ISRCTN注册表的适应性医疗器械RCT.
- 分析年度数量,比例,设计类型,赞助商,治疗领域,试验阶段和确定试验的监管状态.
- 使用自适应设计关键字和医疗器械公司名称来获得全面的搜索术语.
主要成果:
- 在ClinicalTrials.gov上确定了105个适应性医疗器械RCT (每1000个试验中有2.112个试验).
- 与较早的时期相比,自适应性试验的比例在2017-2024年间显著下降 (1.29±0.85每1000次试验).
- 组序列设计 (50.5%),样本大小重新评估 (17.1%) 和优越性/非劣势性调查 (10.5%) 是最常见的适应性设计. 大多数试验都是私人赞助,在欧洲/北美进行,专注于心脏病,并且是市场后的.
结论:
- 在clinicaltrials.gov注册的医疗器械RCT中使用自适应设计在过去十年中已经下降.
- 群组顺序设计,样本大小重新评估和优越性/非劣势性设计仍然是该领域最普遍的适应性策略.
- 与市场前试验相比,市场后试验在适应性设计中表现出更大的多样性.
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