临床试验中P值的意义及结果解读

Interpretation of P value in clinical trials

P值是生物医学研究中最常使用的统计学概念,在临床试验中尤为普遍。但关于P值的意义一直争议不断。本文在对美国统计协会发布的P值声明进行阐述的基础上,介绍《新英格兰医学杂志》发表的两篇关于临床试验获得主要结局P值后的结果解读要点,结合STOP-IgAN和SPRINT两个真实临床试验进行实例解读,期望为研究者正确解读P值、提高临床试验结果报告质量提供遵循依据,得到准确的研究结论。

P value is the most widely used statistical concept in the biomedical study, especially in the clinical trials, but there are controversies over its utility. In this review, we will introduce the American Statistical Association Statement on P values ; in addition, we will summarize the interpretation of P value for the primary outcome achieved in the clinical trials by using STOP-IgAN and SPRINT clinical trials as examples. The purpose of this review is to facilitate a more balanced interpretation of P value, a more qualified clinical trial report and the scientific conclusion process.