1.Institute of Clinical Basic Medicine of Traditional Chinese Medicine, Beijing China Academy of Chinese Medical Sciences, 100007, China; 2.Beijing Kangyitang Institute of Traditional Chinese Medicine, Beijing 100070, China
Abstract：Sample size estimation is a key part of new drug development and clinical promotion in drug clinical trial. Too large or too small sample size will have different degrees of adverse effects on clinical trial, and reasonable sample size is an important guarantee for obtaining high-level clinical research evidence. By combing the relevant literature, this paper sorts out the terminology concepts involved in sample size estimation (such as: null hypothesis and alternative hypothesis, one-sided test and two-sided test, type Ⅰ error and type Ⅱ error, etc.), calculation method (validity test, equivalence test, or non-inferiority test, etc.), and consideration factors (such as σ, δ, α, β, Zα, Zβ, etc.), such as according to different test purposes and test methods, corresponding parameter selection, and sample size estimation formulas are different, standardize the sample size estimation basis in clinical research protocols. Make the research design more scientific and reasonable, so as to improve the research quality of clinical research projects and improve the ability of relevant researchers to analyze and solve problems.
2023, Vol. 20 
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