Titlebook: Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials; Meinhard Kieser Book 2020 The Editor(s) (if appl

秘密会议

Comparison of Three Groups in the Gold Standard Non-Inferiority Designhes are distinguished: the net effect approach, where assessment is based on the pairwise comparisons between placebo, the experimental treatment, and the reference, and the fraction effect approach, where non-inferiority assessment is based on effect retention of the experimental treatment versus the reference relative to placebo.

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Springer Series in Pharmaceutical Statisticshttp://image.papertrans.cn/m/image/632206.jpg

肌肉

武器

Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials978-3-030-49528-2Series ISSN 2366-8695 Series E-ISSN 2366-8709

出来

Comparison of More Than Two Groups and Test for DifferenceIn many clinical trials, more than two interventions are investigated simultaneously thus enabling a head-to-head comparison of different therapeutic options. This chapter provides sample size calculation methods for this situation and the cases of normally distributed, continuous, binary, and time-to-event outcomes.

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Statistical Test and Sample Size Calculatione roles of type I and type II error rates, respectively. Based on these explanations, the general principle of sample size calculation is derived. The basic inequality to be resolved when determining the required sample is given in its general formulation as well as for the special case of normally distributed test statistics.