
Published online:
01 June 2023
Published in print:
01 May 2023
Online ISBN:
9780191993879
Print ISBN:
9780198885238
Contents
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Choosing the sample size Choosing the sample size
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Purpose of the sample size calculation Purpose of the sample size calculation
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Conventional approach to sample size calculations Conventional approach to sample size calculations
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Continuous outcome Continuous outcome
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Sample size for a continuous outcome under a standard trial design Sample size for a continuous outcome under a standard trial design
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Worked example—continuous outcome under a standard trial design Worked example—continuous outcome under a standard trial design
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Binary outcome Binary outcome
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Sample size for a binary outcome under a standard trial design Sample size for a binary outcome under a standard trial design
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Worked example—binary outcome under a standard trial design Worked example—binary outcome under a standard trial design
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Target differences for binary outcomes Target differences for binary outcomes
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Time-to-event outcome Time-to-event outcome
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Sample size for a time-to-event outcome under a standard design Sample size for a time-to-event outcome under a standard design
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Worked example—time-to-event outcome under a standard trial design Worked example—time-to-event outcome under a standard trial design
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Which input values to use? Which input values to use?
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Allowing for missing data Allowing for missing data
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Other approaches to sample size determination Other approaches to sample size determination
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Overview Overview
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Sample size determination for clinical trials focused upon safety Sample size determination for clinical trials focused upon safety
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Precision-based approach Precision-based approach
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Bayesian statistics Bayesian statistics
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Choosing the sample size Choosing the sample size
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Summary Summary
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References References
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Chapter
5 C5Choosing the sample size for a clinical trial
Get access
Pages
107–134
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Published:May 2023
Cite
Cook, Jonathan A., 'Choosing the sample size for a clinical trial', An Introduction to Clinical Trials (Oxford , 2023; online edn, Oxford Academic, 1 June 2023), https://doi.org/10.1093/med/9780198885238.003.0005, accessed 24 Apr. 2025.
Abstract
Getting the sample size right is crucial for ensuring the clinical trial can meet its objectives. It also has practical, financial, and ethical considerations. Why getting the sample size right matters is addressed in this chapter. The chapter explains the purpose of the sample size calculation, and to how to determine the required sample size for binary, continuous and time-to-event outcomes. The inputs needed for each are covered along with what values to use, and worked example calculations are used. Different approaches to sample size determination when assessing safety is the main focus, or a precision-based or Bayesian approach are also described.
Collection:
Oxford Medicine Online
Disclaimer
Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct.
Readers must therefore always …
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Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct.
Readers must therefore always check the product information and clinical procedures with the most up to date published product information and data sheets
provided by the manufacturers and the most recent codes of conduct and safety regulations. The authors and the publishers do not accept responsibility or
legal liability for any errors in the text or for the misuse or misapplication of material in this work. Except where otherwise stated, drug dosages
and recommendations are for the non-pregnant adult who is not breastfeeding.
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