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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2003, Vol. 8 ›› Issue (3): 354-355.

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Lowest sample size and its safety in clinical trials in China

ZHENG Qing-Shan, SUN Rui-Yuan, CHEN Zhi-Yang1   

  1. Anhui Provincial Center for Drug Clinical Evaluation &Yijishan Hospital, Wanan Medical College, Wuhu 241001, Anhui; 1Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei
  • Received:2003-03-28 Revised:2003-03-31 Online:2003-06-26 Published:2020-11-25

Abstract: Sample size should be determined by statistical estimation from efficacy analysis, but the lowest case number is necessary for safety.By calculation of the detection rate of adverse reactions, this paper suggests that the lowest sample sizes are reasonable for Ⅱ, Ⅲ and Ⅳ stage in clinical trials in China.

Key words: biometry, clinical trial, sample size, probability

CLC Number: