适应性队列大小确定方法贝叶斯最佳间隔I/II期设计,以缩短临床试验持续时间.
1Biometrics Department, R&D Division, Kyowa Kirin Co, Ltd, Tokyo, Japan.
JCO precision oncology
|July 24, 2023
概括
本研究引入了针对瘤学试验的适应性队列大小方法. 它通过使用实时数据增加队列大小来缩短试验的持续时间,同时保持准确的最佳生物剂量选择.
科学领域:
- 临床试验 临床试验
- 在瘤学瘤学.
- 生物统计学 生物统计学
背景情况:
- 在瘤学中,剂量优化越来越多地使用II期随机对照试验.
- 从第一阶段数据中选择最佳生物剂量 (OBD) 对第二阶段试验至关重要.
- 目前使用固定队列大小的OBD试验导致延长试验持续时间.
研究的目的:
- 为I期瘤学试验提出一种新的适应性队列大小确定方法.
- 为了缩短OBD选择的试验时间,同时保持准确性.
- 提高癌症研究中剂量检测研究的效率.
主要方法:
- 开发了一种基于毒性和疗效数据得出的可取性概率的适应性队列大小方法.
- 使用预先生成的表格进行队列大小扩展,消除实时可取性概率计算.
- 通过对16种场景进行模拟研究来评估该方法的性能.
主要成果:
- 与传统设计相比,拟议的方法平均减少了20%的试验时间.
- 最佳生物剂量选择的准确性与传统方法相比仍然相当.
- 模拟结果证明了该方法在各种场景中的有效性.
结论:
- 适应性队列大小确定方法有效地减少了瘤学剂量检测研究中的试验持续时间.
- 这种方法保持了最佳生物剂量选择的准确性.
- 该方法为瘤学临床试验设计提供了更有效的策略.
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