Cited by 605Statistical Methods in Clinical TrialsProbability and Statistical ResearchStatistical Methods in Epidemiology

Sample sizes for clinical trials with normal data.

Julious, Steven A.·2004·Statistics in Medicine

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.

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Crossref · 10.1002/sim.1783

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Authors
Julious, S. A.
Affiliations
Northern General Hospital (GB)
Corresponding author
Julious, Steven A.
Venue
Statistics in Medicine
Publisher
Wiley
Published
2004-05-21
Volume
23
Issue
12
Pages
1921-1986
ISSN
  • 0277-6715 (ISSN-L)
  • 1097-0258
OpenAlex
W1997539987
Cited by
605
References
49
Citations by year
2026: 40 · 2025: 51 · 2024: 48 · 2023: 31 · 2022: 36 · 2021: 47 · 2020: 43 · 2019: 46 · 2018: 45 · 2017: 26 · 2016: 32 · 2015: 23 · 2014: 19 · 2013: 20 · 2012: 16
FWCI
1.59
Type
journal article
Language
en
Open access
closed
Locations
  • Statistics in Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Probability and Statistical Research
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Keywords
sample size determination, clinical trials, normal data, crossover trial, superiority, equivalence, non-inferiority, bioequivalence, type I and type II errors
MeSH terms
Biometry, Humans, Research Design, Therapeutic Equivalency, Randomized Controlled Trials as Topic, Sample Size, Cross-Over Studies

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