对适应性试验的系统调查显示,需要大幅改进方法
Yuning Wang1, Minghong Yao1, Jiali Liu1
1Institute of Integrated Traditional Chinese and Western Medicine, Chinese Evidence-based Medicine Center and Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; China Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, China.
Journal of clinical epidemiology
|January 13, 2024
概括
适应性试验可以加速研究,但需要在中间分析,数据监测和处理调整方面进行改进. 这项系统性调查提供了对未来适应性临床试验更好的设计,进行和分析的建议.
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
- 药物开发 药物开发
背景情况:
- 适应性试验设计在临床研究中提供了灵活性和效率.
- 系统审查,以评估适应性试验的设计,进行和分析.
- 确定常见的适应性设计及其方法学特征.
结论:
- 适应性试验需要实质性的方法改进,特别是在中间分析,IDMC建立和管理计划外调整方面.
- 为研究人员提供建议,以加强适应性试验的设计,进行和分析.
- 专注于适应性试验方法的透明度和标准化对于可靠的临床研究至关重要.
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