The role and interpretation of pilot studies in clinical research. Academic Article uri icon

Overview

abstract

  • Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study. The roles and limitations of pilot studies are described here using a clinical trial as an example. A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention. A pilot study is not a hypothesis testing study. Safety, efficacy and effectiveness are not evaluated in a pilot. Contrary to tradition, a pilot study does not provide a meaningful effect size estimate for planning subsequent studies due to the imprecision inherent in data from small samples. Feasibility results do not necessarily generalize beyond the inclusion and exclusion criteria of the pilot design. A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study. Investigators should be forthright in stating these objectives of a pilot study. Grant reviewers and other stakeholders should expect no more.

publication date

  • October 28, 2010

Research

keywords

  • Biomedical Research
  • Clinical Trials as Topic
  • Pilot Projects

Identity

PubMed Central ID

  • PMC3081994

Scopus Document Identifier

  • 79954993735

Digital Object Identifier (DOI)

  • 10.1016/j.jpsychires.2010.10.008

PubMed ID

  • 21035130

Additional Document Info

volume

  • 45

issue

  • 5