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Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (12): 1307-1311.doi: 10.3736/jcim20111205

• Methodology • Previous Articles     Next Articles

Estimation of sample size and testing power (Part 3)

Liang-ping Hu(), Xiao-lei Bao, Xue Guan, Shi-guo Zhou   

  1. Consulting Center of Biomedical Statistics, Academy of Military Medical Sciences, Beijing 100850, China
  • Received:2011-10-19 Accepted:2011-10-21 Online:2011-12-20 Published:2011-12-15

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This article introduces the definition and sample size estimation of three special tests (namely, non-inferiority test, equivalence test and superiority test) for qualitative data with the design of one factor with two levels having a binary response variable. Non-inferiority test refers to the research design of which the objective is to verify that the efficacy of the experimental drug is not clinically inferior to that of the positive control drug. Equivalence test refers to the research design of which the objective is to verify that the experimental drug and the control drug have clinically equivalent efficacy. Superiority test refers to the research design of which the objective is to verify that the efficacy of the experimental drug is clinically superior to that of the control drug. By specific examples, this article introduces formulas of sample size estimation for the three special tests, and their SAS realization in detail.

Key words: statistics, medical, research design, sample size, testing power, parametric estimation

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Group n Frequency Effective rate (%)
Effective Ineffective
Experimental drug (or appliance) nT a b PT
Control drug (or appliance) nC c d PC
[1] Tao LX, Hu LP, Zhou SG . Conduct of three special tests for comparing two proportions from two-group parallel design with SAS. Yao Xue Fu Wu Yu Yan Jiu. 2010 ; 10(6) : 409-412. Chinese with abstract in English.
doi: 10.5428/pcar20100603
陶丽新, 胡良平, 周诗国 . 成组设计定性资料的三种特殊检验及其SAS实现.药学服务与研究. 2010; 10(6) : 409-412.
doi: 10.5428/pcar20100603
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