Points to Consider on Adjustment for Baseline Covariates への意見 [in Japanese] Comments on "Points to Consider on Adjustment for Baseline Covariates" [in Japanese]
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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.
- Japanese Journal of Biometrics
Japanese Journal of Biometrics 27, S8-S15, 2006-09-30
The Biometric Society of Japan