A brief overview of pilot studies and their sample size justification

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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.

Original languageEnglish (US)
JournalFertility and sterility
StateAccepted/In press - 2024

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

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