三角洲通货膨胀,乐观偏见和临床试验中的不确定性
Charles C Liu1, Peiwen Wu2, Ron Xiaolong Yu2
1Department of Biostatistics, Gilead Sciences, 333 Lakeside Drive, Foster City, CA, 94404, USA. cliu17@gilead.com.
Therapeutic innovation & regulatory science
|September 6, 2024
概括
德尔塔通货膨胀,即试验效应超过现实世界的结果,可能源于临床平衡,而不仅仅是乐观偏见. 试验前真正的不确定性为这种常见现象提供了新的解释.
科学领域:
- 临床试验 临床试验
- 医学研究方法学 医学研究方法学
- 生物统计学 生物统计学
背景情况:
- 与观察结果相比,在试验设计中对治疗效果的高估,即三角形通货膨胀是一个公认的问题.
- 这种现象通常归因于研究人员对新疗法的乐观偏见.
研究的目的:
- 提出临床平衡作为三角洲通胀的替代解释.
- 探索评估调查人员信念和试验不确定性的方法.
主要方法:
- 关于三角洲通货膨胀和乐观偏差的现有文献的审查.
- 讨论像贝叶斯先验和预测分析这样的替代方法.
- 检查明确不确定性表达在试验设计中的作用.
主要成果:
- 德尔塔通胀可能自然来自临床平衡 (真正的不确定性),而不是仅仅来自乐观偏见.
- 对乐观偏见的证据是混合的,并且取决于试验设计期间明确声明的不确定性.
结论:
- 临床平衡为解释三角洲通货膨胀提供了对乐观偏见的可信替代方案.
- 评估研究人员的信念需要在试验设计阶段明确量化不确定性.
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