Pilot experiment
A pilot experiment, pilot study, pilot test or pilot project is a small-scale preliminary study conducted to evaluate feasibility, duration, cost, adverse events, and improve upon the study design prior to performance of a full-scale research project.[1][2]
Implementation
Pilot experiments are frequently carried out before large-scale quantitative research, in an attempt to avoid time and money being used on an inadequately designed project. A pilot study is usually carried out on members of the relevant population.[1] A pilot study is used to formulate the design of the full-scale experiment which then can be adjusted.[1][2] The pilot study is potentially a critical insight to clinical trial design, recruitment and sample size of participants, treatment testing, and statistical analysis to improve the power of testing the hypothesis of the study.[2] Analysis from the pilot experiment can be added to the full-scale (and more expensive) experiment to improve the chances of a clear outcome.[1][2]
Applications
In sociology, pilot studies can be referred to as small-scale studies that will help identify design issues before the main research is done. Although pilot experiments have a well-established tradition, their usefulness as a strategy for change has been questioned, at least in the domain of environmental management.[3] Extrapolation from a pilot study to large scale strategy may not be assumed as possible, partly due to the exceptional resources and favorable conditions that accompany a pilot study.[1]
In clinical research, studies conducted in preparation for a future randomized controlled trial are known as "pilot" and "feasibility" studies, where pilot studies are a subset of feasibility studies.[1][4] A feasibility study asks whether the study should proceed, and if so, how. A pilot study asks the same questions, but also has a specific design feature: in a pilot study, a future study is conducted on a smaller scale,[1][5] which, if having produced positive results, may lead to a Phase I clinical trial.[6] The use of pilot and feasibility studies to estimate treatment effect is controversial, with ongoing methodologic discussion about appropriateness.[7]
A checklist was published in 2016 to provide guidance on how to report pilot trials.[8]
See also
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 "A tutorial on pilot studies: the what, why and how". BMC Medical Research Methodology 10 (1): 1. January 2010. doi:10.1186/1471-2288-10-1. PMID 20053272.
- ↑ 2.0 2.1 2.2 2.3 "Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!". Pilot and Feasibility Studies 7 (1): 40. February 2021. doi:10.1186/s40814-021-00770-x. PMID 33536076.
- ↑ "Action without change? On the use and usefulness of pilot experiments in environmental management.". SAPIEN. Surveys and Perspectives Integrating Environment and Society. 4 (1). February 2010. http://sapiens.revues.org/index979.html.
- ↑ "The role and interpretation of pilot studies in clinical research". Journal of Psychiatric Research 45 (5): 626–629. May 2011. doi:10.1016/j.jpsychires.2010.10.008. PMID 21035130.
- ↑ "Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework". PLOS ONE 11 (3): e0150205. 2016. doi:10.1371/journal.pone.0150205. PMID 26978655. Bibcode: 2016PLoSO..1150205E.
- ↑ "The drug development process: Step 3: Clinical research". US Food and Drug Administration. 4 January 2018. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research.
- ↑ "Should treatment effects be estimated in pilot and feasibility studies?". Pilot and Feasibility Studies 5 (1): 107. December 2019. doi:10.1186/s40814-019-0493-7. PMID 31485336.
- ↑ "CONSORT 2010 statement: extension to randomised pilot and feasibility trials". BMJ 355: i5239. October 2016. doi:10.1136/bmj.i5239. PMID 27777223.
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