crm12comb:基于CRM设计的药物组合的I/II阶段适应性设计,通过R通过R
Junying Wang1, Song Wu1, Jie Yang2
1Department of Applied Mathematics and Statistics, Stony Brook University, Stony Brook, United States of America.
这项研究介绍了crm12Comb,这是用于药物组合适应性I/II期临床试验的R包. 它通过使用持续重新评估方法 (CRM) 简化了剂量发现,以改善癌症治疗的发展.
科学领域:
- 临床药理学 临床药理学
- 生物统计学 生物统计学
- 计算生物学 计算生物学
背景情况:
- 适应性设计可以加速药物开发并提高疗效,特别是在瘤学中.
- 持续重新评估方法 (CRM) 是贝叶斯的临床试验中剂量确定方法.
- 综合性I/II期试验结合了药物组合的剂量发现和早期疗效评估.
研究的目的:
- 推出crm12Comb,一个旨在简化药物组合适应性I/II期临床试验设计的R包.
- 提供指导患者分配和执行模拟来评估试验运行特征的工具.
- 提供一个灵活的平台,容纳各种试验参数和结果类型.
主要方法:
- 开发crm12Comb R包,实现适应性试验设计的CRM.
- 将剂量-毒性和剂量-疗效关系的部分顺序与二进制结果相结合.
- 支持用户指定的参数,包括队列大小,药物组合和以前的分布.
主要成果:
- crm12Comb包可在累积试验数据的基础上简化患者分配.
- 它可以进行全面的模拟研究,以评估不同适应性设计参数的性能.
- 该包提供模拟结果的视觉表示,以便更好地解释.
结论:
- crm12Comb提高了药物组合适应性I/II期试验的效率和灵活性.
- 该套件支持在瘤药物开发中进行可靠的剂量寻找和运行特征评估.
- 它为设计和模拟复杂临床试验的研究人员提供了宝贵的资源.
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