临床试验中的意向治疗和方案分析。

Intention to treat and per protocol analysis in clinical trials.

机构信息

CNR-IFC, Clinical Epidemiology and Pathophysiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.

ERA-EDTA Registry, Department of Medical Informatics, Academic Medical Center, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.

出版信息

Nephrology (Carlton). 2020 Jul;25(7):513-517. doi: 10.1111/nep.13709. Epub 2020 Mar 15.

DOI:10.1111/nep.13709

PMID:32147926

Abstract

In clinical epidemiology, experimental studies usually take the form of randomized controlled clinical trials (RCTs). The data analysis of an RCT can be performed by using two complementary strategies, that is according to the intention to treat (ITT) principle and the per protocol (PP) analysis. By using the ITT approach, investigators aim to assess the effect of assigning a drug whereas by adopting the PP analysis, researchers investigate the effect of receiving the assigned treatment, as specified in the protocol. Both ITT and PP analyses are essentially valid but they have different scopes and interpretations dependent on the context.

摘要

在临床流行病学中，实验研究通常采用随机对照临床试验（RCT）的形式。RCT 的数据分析可以采用两种互补策略进行，即根据意向治疗（ITT）原则和方案（PP）分析。使用 ITT 方法，研究者旨在评估分配药物的效果，而采用 PP 分析，研究人员则根据方案规定调查接受指定治疗的效果。ITT 和 PP 分析本质上都是有效的，但它们的范围和解释取决于具体情况。