优效性、非劣效性和等效性试验的比较
Comparisons of Superiority, Non-inferiority, and Equivalence Trials.
作者信息
Wang Bokai, Wang Hongyue, Tu Xin M, Feng Changyong
机构信息
Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.
Division of Biostatistics, University of California San Diego, La Jolla, CA, USA.
出版信息
Shanghai Arch Psychiatry. 2017 Dec 25;29(6):385-388. doi: 10.11919/j.issn.1002-0829.217163.
Abstract
Efficacy of a new drug or treatment is usually established through randomized clinical trials. However, specifying hypotheses remains a challenging problem for biomedical researchers. In this survey we discuss superiority, non-inferiority, and equivalence trials. These three types of trials have different assumptions on treatment effects. We compare the assumptions underlying these trials and provide sample size formulas.
摘要
一种新药或新疗法的疗效通常通过随机临床试验来确定。然而，对生物医学研究人员来说，确定假设仍然是一个具有挑战性的问题。在本次调查中，我们讨论优效性试验、非劣效性试验和等效性试验。这三种类型的试验对治疗效果有不同的假设。我们比较了这些试验背后的假设，并给出了样本量计算公式。
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