http://www3.interscience.wiley.com/journal/108567017/abstract


Tutorial in Biostatistics

Sample sizes for clinical trials with Normal data

Steven A. Julious[size=-1] *

Institute of General Practice and Community Care, Community Science Centre, Northern General Hospital, Herries Road, Sheffield, S5 7AU, U.K.

email: Steven A. Julious (S.A.Julious@sheffield.ac.uk)

[size=-1]*Correspondence to Steven A. Julious, Medical Statistics Unit, Institute of General Practice and Community Care, Community Science Centre, Northern General Hospital, Herries Road, Sheffield, S5 7AU, U.K.

Keywords

sample size • power • type I error • type II error • superiority trials • equivalence trials • non-inferiority trials • bioequivalence • precision • baselines • cross-over trials • parallel group trials

Abstract

This article gives an overview of sample size calculations for parallel group and cross-over studies with Normal data. Sample size derivation is given for trials where the objective is to demonstrate: superiority, equivalence, non-inferiority, bioequivalence and estimation to a given precision, for different types I and II errors. It is demonstrated how the different trial objectives influence the null and alternative hypotheses of the trials and how these hypotheses influence the calculations. Sample size tables for the different types of trials and worked examples are given. Copyright © 2004 John Wiley & Sons, Ltd.