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

上海精神医学 Pub Date : 2017-12-25 DOI:10.11919/j.issn.1002-0829.217163

Bokai Wang, Hongyue Wang, Xin M Tu, Changyong Feng

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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

上海精神医学

自引率

0.00%

发文量

2341

期刊介绍： Shanghai archives of psychiatry (bimonthly) was founded in 1959 and is sponsored by Shanghai Mental Health Center. The journal is aimed at mental health workers across the country, including psychiatrists and nurses, clinical psychologists, social workers, and people who are committed to the cause of mental health. It focuses on reporting clinical research results and practical experience in the field of psychiatry, and introduces the latest knowledge in psychiatry and related fields. The columns include monographs, case reports, clinical case discussions, reviews, mental health and law, and debates and discussions.