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Review
. 2024 Jun;121(6):899-901.
doi: 10.1016/j.fertnstert.2024.01.040. Epub 2024 Feb 6.

A brief overview of pilot studies and their sample size justification

Allen R Kunselman  1
Affiliations
Review

A brief overview of pilot studies and their sample size justification

Allen R Kunselman. Fertil Steril. 2024 Jun.

Erratum in

  • [No title available]
    [No authors listed] [No authors listed] Fertil Steril. 2024 Dec;122(6):1169. doi: 10.1016/j.fertnstert.2024.09.036. Epub 2024 Oct 24. Fertil Steril. 2024. PMID: 39453345 No abstract available.

Abstract

Pilot studies, when properly designed and implemented, are an important tool that provide critical information for the development and potential success of a subsequent, larger trial. In fact, these small-scale studies are commonly used to assess the feasibility of whether a larger trial should be initiated. A popular investigator question is whether a pilot study requires a formal statistical power calculation. In general, the answer is "no"; however, the sample size needs to be justified on the basis of the goal of the pilot study.

Keywords: Pilot study; feasibility; sample size.

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Conflict of interest statement

Declaration of Interests A.R.K. declares stock ownership in Merck.

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