Abstract
Pilot studies are small-scale clinical research endeavors that are conducted to examine the feasibility of an experimental approach for a subsequent larger study, often a randomized clinical trial. Pilot studies and their resultant data are becoming more popular as the costs for clinical trials increase and the availability of funding decreases among trial sponsors. Pilot studies are commonly done to assess recruitment potential; to assess the feasibility of coordination of sites across multicenter trials; and to assess the intervention (or demonstrate success in intervention delivery) for the Phase III trials. Conducting a pilot study can identify important barriers to the success of the main trial and can assist investigators in developing creative solutions to the identified barriers. The objective of this chapter is to provide a detailed examination of the key issues of the design and conduct of pilot studies done in a clinical research setting.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011;4(5):332–7.
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new medical research council guidance. BMJ. 2008;29(337):a1655.
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10(1):1.
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011;45(5):626–9.
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval clin Pract. 2004;10(2):307–12.
Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990;9(1–2):65–72.
Cook DJ, Rocker G, Meade M, Guyatt G, Geerts W, Anderson D, Skrobik Y, Hebert P, Albert M, Cooper J, Bates S. Prophylaxis of thromboembolism in critical care (PROTECT) trial: a pilot study. J Crit Care. 2005;20(4):364–72.
Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom clinical research network database. BMC Med Res Methodol. 2013;13(1):1.
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006;63(5):484–9.
Halpern SD, Karlawish JH, Berlin JA. The continuing unethical conduct of underpowered clinical trials. JAMA. 2002;288(3):358–62.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing AG
About this chapter
Cite this chapter
Ferguson, R.E., Brophy, M.T. (2017). Pilot Studies. In: Itani, K., Reda, D. (eds) Clinical Trials Design in Operative and Non Operative Invasive Procedures. Springer, Cham. https://doi.org/10.1007/978-3-319-53877-8_27
Download citation
DOI: https://doi.org/10.1007/978-3-319-53877-8_27
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-53876-1
Online ISBN: 978-3-319-53877-8
eBook Packages: MedicineMedicine (R0)