Pilot studies are research studies which
produce no direct benefit to the research community, but rather which provide benefit through assisting
with the planning of a future research study. These pages present some of the
issues associated with running a pilot study. Also see Category: Survey design. Other entries about pilot studies can be found in the
pilot studies page at the
StATS website.
2010
- P.Mean: Pilot study (created 1999-09-03,
updated 2010-07-08). Dear Professor Mean, I am proposing a
research study that will examine a complex intervention of diet, exercise, and
behavioral modification for some of my pediatric patients who need to lose
weight. I want to collect some data from a pilot study before I start the
research study. How do I describe the pilot study in my protocol? --
Sophisticated Sarah
Outside resources:
- Lehana Thabane, Jinhui Ma, Rong Chu, et al. A tutorial on pilot
studies: the what, why and how. BMC Medical Research Methodology.
2010;10(1):1. Abstract: "Pilot studies for phase III trials - which are
comparative randomized trials designed to provide preliminary evidence on
the clinical efficacy of a drug or intervention - are routinely performed in
many clinical areas. Also commonly know as "feasibility" or "vanguard"
studies, they are designed to assess the safety of treatment or
interventions; to assess recruitment potential; to assess the feasibility of
international collaboration or coordination for multicentre trials; to
increase clinical experience with the study medication or intervention for
the phase III trials. They are the best way to assess feasibility of a
large, expensive full-scale study, and in fact are an almost essential
pre-requisite. Conducting a pilot prior to the main study can enhance the
likelihood of success of the main study and potentially help to avoid doomed
main studies. The objective of this paper is to provide a detailed
examination of the key aspects of pilot studies for phase III trials
including: 1) the general reasons for conducting a pilot study; 2) the
relationships between pilot studies, proof-of-concept studies, and adaptive
designs; 3) the challenges of and misconceptions about pilot studies; 4) the
criteria for evaluating the success of a pilot study; 5) frequently asked
questions about pilot studies; 7) some ethical aspects related to pilot
studies; and 8) some suggestions on how to report the results of pilot
investigations using the CONSORT format." [Accessed July 12, 2010].
Available at:
http://www.biomedcentral.com/1471-2288/10/1.
All of the material above this paragraph is licensed under a
Creative Commons Attribution 3.0 United States License. This page was written by
Steve Simon and was last modified on
2010-07-12. The material
below this paragraph links to my
old website, StATS. Although I wrote all of the material
listed below, my ex-employer, Children's Mercy Hospital, has claimed copyright
ownership of this material. The brief excerpts shown here are included under
the fair use provisions of U.S. Copyright laws.
2004
-
Stats: Design and
analysis of pilot studies (September 17, 2004).
A colleague sent me a very nice paper, Design and
analysis of pilot studies: recommendations for good practice. G. A.
Lancaster, S. Dodd, P. R. Williamson. J Eval Clin Pract 2004: 10(2); 307-12,
that covers some of the same ideas in my web page, Stats: Designing a pilot
study.
1999
- Stats: Designing a pilot study (September 13,
1999). Dear Professor Mean, I am
proposing a research study that will examine a complex intervention of diet,
exercise, and behavioral modification for some of my pediatric patients who
need to lose weight. I want to collect some data from a pilot study before I
start the research study. How do I describe the pilot study in my protocol?
-- Sophisticated Sarah
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