关于非核心协议数据的理由和相关性的案例研究评估
1Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA. zak.smith@tufts.edu.
Therapeutic innovation & regulatory science
|December 1, 2023
概括
赞助商公司和FDA审查员在临床试验程序上达成了一些协议. 然而,FDA将更多的程序归类为非核心程序,强调需要更好的沟通来简化试验协议.
科学领域:
- 临床试验的管理管理.
- 监管科学是一种监管科学.
- 药物开发 药物开发
背景情况:
- 临床试验中的非核心程序可能会使协议设计和优化变得复杂.
- 了解收集非核心数据的合理性和相关性对于简化试验至关重要.
研究的目的:
- 评估赞助商公司与食品和药物管理局 (FDA) 在非核心协议程序的分类和相关性方面的一致性.
- 在关键试验中识别核心与非核心数据收集的看法中的差异.
主要方法:
- 塔夫斯CSDD与12家赞助公司和FDA审查员合作.
- 赞助商从19个关键试验中分类和评分了700个程序;FDA审查员评估了3个试验中的80个程序.
主要成果:
- 超过一半的终点显示赞助商和FDA审查人员在分类方面达成一致.
- 美国食品和药物管理局审查人员发现,非核心程序的比例较高 (26%与18%),其中50%被赞助商认为是核心程序.
- 赞助商引用了16%的非核心程序的感知监管要求.
结论:
- 在非核心程序的分类中存在显著的错位,影响了协议简化工作.
- 加强FDA与赞助商之间的沟通对于调整要求和优化临床试验设计至关重要.
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