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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2006, Vol. 11 ›› Issue (12): 1433-1436.

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Simply introduced the application of grouPsequential design in clinical test

LI Xian-tao, LIANG Wei-xiong1, ZHANG Bo-li   

  1. Research Center of TCM, Tianjin University of TCM, Tianjin 300193, China;
    1DME Center, Guangzhou University of TCM, Guangzhou 510407, Guangdong, China
  • Received:2006-09-15 Revised:2006-10-30 Online:2006-12-26 Published:2020-11-06

Abstract: In clinical trials, interim analyses are usually performed for ethical or economical reasons.GrouPsequential design was the method of interim analysis recommended by ICH-GCP.The principle of grouPsequential design and its several questions:times of interim analysis, the value of statistic test, the sample estimate,selection of endpoints and others were introduced in this article.

Key words: grouPsequential design, interim analysis, clinical trials, repeated measurement

CLC Number: