Pilot experiment explained

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

• Dry run (testing)
• Mass production
• Mock-up
• Pilot plant
• Proof of concept
• Prototype

Notes and References

1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH . 6 . A tutorial on pilot studies: the what, why and how . BMC Medical Research Methodology . 10 . 1 . 1 . January 2010 . 20053272 . 2824145 . 10.1186/1471-2288-10-1 . free .
2. Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA . Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! . Pilot and Feasibility Studies . 7 . 1 . 40 . February 2021 . 33536076 . 7856754 . 10.1186/s40814-021-00770-x . free .
3. Billé R, Duchemin B . Action without change? On the use and usefulness of pilot experiments in environmental management. . SAPIEN. Surveys and Perspectives Integrating Environment and Society. . February 2010 . 4 . 1 .
4. Leon AC, Davis LL, Kraemer HC . The role and interpretation of pilot studies in clinical research . Journal of Psychiatric Research . 45 . 5 . 626–629 . May 2011 . 21035130 . 3081994 . 10.1016/j.jpsychires.2010.10.008 .
5. Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM . Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework . PLOS ONE . 11 . 3 . e0150205 . 2016 . 26978655 . 4792418 . 10.1371/journal.pone.0150205 . 2016PLoSO..1150205E . free .
6. Web site: The drug development process: Step 3: Clinical research . US Food and Drug Administration . 29 March 2021 . 4 January 2018.
7. Sim J . Should treatment effects be estimated in pilot and feasibility studies? . Pilot and Feasibility Studies . 5 . 1 . 107 . December 2019 . 31485336 . 6712606 . 10.1186/s40814-019-0493-7 . free .
8. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA . PAFS Consensus Group . CONSORT 2010 statement: extension to randomised pilot and feasibility trials . BMJ . 355 . i5239 . October 2016 . 27777223 . 5076380 . 10.1136/bmj.i5239 .