一项模拟研究,比较瘤学剂量优化中的回填和随机扩张
Huan Cheng1, Xiaoyun Nicole Li1
1Global Statistics and Data Science, BeOne Medicines, San Carlos, USA.
Journal of biopharmaceutical statistics
|February 19, 2026
概括
与同质环境中的两阶段扩张设计相比,单阶段的回填设计可以减少研究时间和样本大小,以优化剂量. 效用监测提高了效率,但填充设计对异质性敏感.
科学领域:
- 临床试验设计 临床试验设计
- 生物统计学 生物统计学
- 药学指标 (Pharmacometrics) 是一个指标.
背景情况:
- 剂量优化对于药物开发至关重要.
- 两个常见的设计是两个阶段的扩张和一个阶段的回填.
- 对于这些设计,只有有限的比较研究存在.
研究的目的:
- 为了比较两个阶段的扩张和一个阶段的回填设计的性能.
- 在各种场景下评估剂量选择方法.
- 评估后填充设计中徒劳性监测和患者排除的影响.
主要方法:
- 进行了全面的模拟研究.
- 基于规则的,基于实用性的和基于模型的剂量选择方法进行比较.
- 评估设计与或没有失衡因素和徒劳性监测.
主要成果:
- 填充设计可以缩短研究持续时间,并减少样本大小在均的设置.
- 功率监控可以提高效率,并减少功耗损失.
- 填充后设计对延迟有效性或异质性更敏感.
结论:
- 一个阶段的回填设计对于同质群体是有效的.
- 双阶段扩展设计在异质环境中提供了更大的稳定性.
- 设计选择取决于人口特征和研究目标.
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