Statistical adjustment of treatment effect for covariates in clinical trials
- VernacularTitle:临床试验中评价处理效应的协变量调整问题
- Author:
Yuxiu LIU
;
Chen YAO
;
Feng CHEN
;
Qiguang CHEN
;
Binghua SU
;
- Publication Type:Journal Article
- Keywords:
clinical trial;
treatment effect;
covariate;
stratification;
minimization;
stratified tests;
regression model;
ICH
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(03):-
- CountryChina
- Language:Chinese
-
Abstract:
Some non treatment variables that affect the outcome of a disease are often called covariates. These covariables should be considered in the design and analysis of clinical trials to obtain unbias conclusion. To ensure that any observed treatment effect is not influenced by an imbalances in baseline characteristics, both preadjustment and postadjustment are provided in the design stage and analysis stage of the trials respectively. They can improve the credibility of the trial results and increase the statistical efficiency. Based on a few papers published about adjustment for covariates and some documentations of the International Conference on Harmonization (ICH), we review the concepts, methods and procedures for adjustment of treatment effects for the influence of covariates. The statistical issues on the application of adjustment are especially discussed in great depth.
