著者
萩野 篤司
出版者
日本計量生物学会
雑誌
計量生物学 (ISSN:09184430)
巻号頁・発行日
vol.27, no.Special_Issue, pp.S8-S15, 2006-09-30 (Released:2012-01-23)
参考文献数
12

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.