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Design and Optimization Strategies of a High-Performance Vented Box
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提示加速BOIN设计的方法
Masahiro Kojima1, Wu Wende2, Henry Zhao2
1Biometrics Department, Research Division, Kyowa Kirin Co., Ltd. Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-004, Japan. kojima.masahiro@ism.ac.jp.
Therapeutic innovation & regulatory science
|September 2, 2024
概括
我们开发了一个加速的贝叶斯最佳间隔 (BOIN) 设计,以加快早期临床试验. 这种新方法与传统的3+3设计的速度相匹配,减少了研究持续时间和患者数量.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 药物开发 药物开发
背景情况:
- 标准的3+3设计被广泛用于剂量升级,但可能是漫长的.
- BOIN设计提供了统计上的优势,但由于研究持续时间较长和样本规模较大,它面临着采用障碍.
研究的目的:
- 为I期临床试验引入加速的BOIN设计.
- 为了使BOIN设计能够达到与3+3设计相提并论的速度.
- 为了证明BOIN设计在一个主要使用3+3设计的公司中的适用性.
主要方法:
- 通过整合一个高效的停止标准,开发了一个加速的BOIN设计.
- 拟议的方法涉及终止剂量升级,如果6名患者在当前剂量可评估和决定是留下来.
- 对于较低剂量,如果非临床研究没有显示出安全问题,则较小的队列规模被认为是可行的.
主要成果:
- 与标准BOIN设计相比,加速BOIN设计在正确的最大耐受剂量 (MTD) 选择中显示出 -2.43%的平均差异.
- 加快的BOIN设计使平均研究时间减少了14.8个月.
- 与标准BOIN设计相比,平均样本大小减少了9.22名患者.
结论:
- 加速BOIN设计为剂量升级提供了3+3设计的可行替代方案.
- 这种加速方法保持了统计学严谨性,同时提高了试验效率.
- 这些发现支持在早期瘤学试验中更广泛地采用BOIN设计.
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