Julious, S.A. orcid.org/0000-0002-9917-7636 (2005) Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics, 4 (4). pp. 287-291. ISSN 1539-1604
Abstract
When designing a clinical trial an appropriate justification for the sample size should be provided in the protocol. However, there are a number of settings when undertaking a pilot trial when there is no prior information to base a sample size on. For such pilot studies the recommendation is a sample size of 12 per group. The justifications for this sample size are based on rationale about feasibility; precision about the mean and variance; and regulatory considerations. The context of the justifications are that future studies will use the information from the pilot in their design.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2005 John Wiley & Sons, Ltd. |
Keywords: | sample size; pilot study; CLINICAL-TRIALS |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 05 Aug 2022 14:11 |
Last Modified: | 05 Aug 2022 14:11 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1002/pst.185 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:189736 |