Comparisons of Superiority, Non-inferiority, and Equivalence Trials.

Bokai Wang, Hongyue Wang, Xin M Tu, Changyong Feng
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引用次数: 16

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.

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优势试验、非劣效试验和等效试验的比较。
一种新药或新疗法的疗效通常是通过随机临床试验确定的。然而,对于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。在这个调查中,我们讨论了优势,非劣效和等效试验。这三种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,并提供了样本量公式。
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