Comments on “Points to Consider on Adjustment for Baseline Covariates”

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  • Points to Consider on Adjustment for Baseline Covariatesへの意見
  • Points to Consider on Adjustment for Baseline Covariates エ ノ イケン

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Abstract

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.

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