話題1：Points to Consider on Adjustment for Baseline Covariates
Points to Consider on Adjustment for Baseline Covariatesへの意見
2006 年 27 巻 Special_Issue 号 p. S8-S15
詳細
2006 年 27 巻 Special_Issue 号 p. S8-S15
In May 2003, the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a guidance regarding the adjustment for covariates entitled “Points to Consider on Adjustment for Baseline Covariates”. This article provides a summary of the guidance and specifically discusses the use of dynamic allocation from the viewpoint that advocates the necessity of pre-stratification in clinical trials.
