Recommendations for planning pilot studies in clinical and translational research.

Charity G. Moore, Rickey E. Carter, Paul J. Nietert, Paul W. Stewart

Research output: Contribution to journalReview article

163 Scopus citations

Abstract

Advances in clinical and translation science are facilitated by building on prior knowledge gained through experimentation and observation. In the context of drug development, preclinical studies are followed by a progression of phase I through phase IV clinical trials. At each step, the study design and statistical strategies are framed around research questions that are prerequisites for the next phase. In other types of biomedical research, pilot studies are used for gathering preliminary support for the next research step. However, the phrase "pilot study" is liberally applied to projects with little or no funding, characteristic of studies with poorly developed research proposals, and usually conducted with no detailed thought of the subsequent study. In this article, we present a rigorous definition of a pilot study, offer recommendations for the design, analysis and sample size justification of pilot studies in clinical and translational research, and emphasize the important role that well-designed pilot studies play in the advancement of science and scientific careers.

Original languageEnglish (US)
Pages (from-to)332-337
Number of pages6
JournalClinical and translational science
Volume4
Issue number5
DOIs
StatePublished - Oct 2011

ASJC Scopus subject areas

  • Neuroscience(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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