Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non‐zero risk difference or non‐unity relative risk

作者：Conor P. Farrington, Godfrey Manning · 发表于：Statistics in Medicine · 年份：1990 · DOI：10.1002/sim.4780091208 · 被引用次数：663 · 研究领域：Statistical Methods in Clinical Trials、Health Systems, Economic Evaluations, Quality of Life、Healthcare Policy and Management

When it is required to establish a materially significant difference between two treatments, or, alternatively, to show that two treatments are equivalent, standard test statistics and sample size formulae based on a null hypothesis of no difference no longer apply. This paper reviews some of the test statistics and sample size formulae proposed for comparative binomial trials when the null hypothesis is of a specified non-zero difference or non-unity relative risk. Methods based on restricted maximum likelihood estimation are recommended and applied to studies of pertussis vaccine.