强迫随机化:什么,为什么,以及如何
Kerstine Carter1, Olga Kuznetsova2, Volodymyr Anisimov3
1Boehringer-Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA.
BMC medical research methodology
|October 8, 2024
概括
临床试验中的强制随机化 (FR) 通过防止药物供应问题,提高了患者的体验和效率. 精心规划和供应策略确保随机对照试验 (RCT) 中的风险和治疗不平衡最小.
科学领域:
- 临床试验设计 临床试验设计
- 药学研究 药学研究
- 生物统计学 生物统计学
背景情况:
- 临床场所可能会遇到这样的情况:由于在场所无法提供治疗,因此无法随机选择符合条件的参与者.
- 交互响应技术 (IRT) 允许"强制随机化" (FR) 将参与者分配到可用的治疗臂中.
- 行业共识表明,如果实例有限,但统计性质需要进一步了解,则在确认性试验中可以接受FR.
研究的目的:
- 探索随机对照试验 (RCT) 中强制随机化 (FR) 的统计特性和实际影响.
- 在使用FR时,评估不同IRT配置和药物供应策略对试验操作的影响.
- 为开发和评估结合FR的随机化设计提供框架.
主要方法:
- 描述了四个具有和没有FR的IRT配置,用一个例子说明.
- 进行了数据库搜索 (Cortellis),以确定FR在临床实践中的流行率.
- 开发了一个用于评估FR设计的模板,并将其应用于各种招聘和供应场景下的假设多中心RCT,并使用Julia代码进行模拟.
主要成果:
- FR可以消除患者拒绝,改善物流,药物管理,成本效益,减少招聘时间.
- 科特利斯的搜索显示,FR的使用报告有限,通常记录在IRT规范中.
- 模拟表明,在现实的环境中,FR的百分比较低;FR的补充和高补给减少了治疗失衡和招聘时间,而药物过量主要受到补给策略的影响.
结论:
- 当与适当的药物供应策略相结合时,FR可显著改善患者/现场体验,试验物流和效率.
- FR有效地防止拒绝和揭开盲目,有助于更顺利地进行审判.
- 当正确规划和实施时,FR是多中心RCT的有价值特征.
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