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Cited by 452Statistical Methods in Clinical TrialsStatistical Methods in EpidemiologyMeta-analysis and systematic reviews

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Sample Size Estimation in Clinical Research

Wang, Xiaofeng, Ji, Xinge·2020·Chest
DOI 10.1016/j.chest.2020.03.010
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Abstract

Sample size determination is an essential step in planning a clinical study. It is critical to understand that different study designs need different methods of sample size estimation. Although there is a vast literature discussing sample size estimation, incorrect or improper formulas continue to be applied. This article reviews basic statistical concepts in sample size estimation, discusses statistical considerations in the choice of a sample size for randomized controlled trials and observational studies, and provides strategies for reducing sample size when planning a study. To assist clinical researchers in performing sample size calculations, we have developed an online calculator for common clinical study designs. The calculator is available at http://riskcalc.org:3838/samplesize/. Finally, we offer our recommendations on reporting sample size determination in clinical studies.

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Research works printed but not linked: 14

  1. Wittes, 2002, Sample size calculations for randomized controlled trials, Epidemiol Rev, 24, 39, 10.1093/epirev/24.1.39 · DOI
  2. Eng, 2003, Sample size estimation: how many individuals should be studied?, Radiology, 227, 309, 10.1148/radiol.2272012051 · DOI
  3. Kasiulevičius, 2006, Sample size calculation in epidemiological studies, Gerontologija, 7, 225
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  7. Gagnier, 2014, The CARE guidelines: consensus-based clinical case report guideline development, J Clin Epidemiol, 67, 46, 10.1016/j.jclinepi.2013.08.003 · DOI
  8. Hopewell, 2010, The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed, BMJ, 340, c723, 10.1136/bmj.c723 · DOI · Paper page
  9. Lipsitz, 1995, Sample size calculations for non-randomized studies, J R Stat Soc Ser D Stat, 44, 81
  10. Bernardo, 2000, Sample size calculations for failure time random variables in non-randomized studies, J R Stat Soc Ser D Stat, 49, 31
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  13. Henry GT. Practical Sampling. vol 21. Newbury Park, CA: SAGE Publications Ltd.; 1990.
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Metadata

Authors
Wang, X., & Ji, X.
Affiliations
Cleveland Clinic (US)
Corresponding author
Wang, Xiaofeng
ORCID
Wang, Xiaofeng
Venue
Chest
Publisher
Elsevier BV
Published
2020-07
Volume
158
Issue
1
Pages
S12-S20
ISSN
0012-3692 (ISSN-L)
DOI
10.1016/j.chest.2020.03.010
OpenAlex
W3039422431
Cited by
452
References
0
Citations by year
2026: 87 · 2025: 105 · 2024: 121 · 2023: 76 · 2022: 36 · 2021: 22 · 2020: 4
FWCI
24.19
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • CHEST Journal (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
sample size determination, randomized controlled trials, observational studies, clinical research design, statistical power
MeSH terms
Humans, Research Design, Randomized Controlled Trials as Topic, Sample Size, Observational Studies as Topic

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