Pilot experiment

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A pilot study, pilot project, pilot test, or pilot experiment 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[edit]

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[edit]

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] 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][4] which, if having produced positive results, may lead to a Phase I clinical trial.[5]

A checklist was published in 2016 to provide guidance on how to report pilot trials.[6]

See also[edit]

References[edit]

  1. ^ a b c d e f g Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH (2010). "A tutorial on pilot studies: the what, why and how". BMC Med Res Methodol. 10 (1): 1. doi:10.1186/1471-2288-10-1. PMC 2824145. PMID 20053272.
  2. ^ a b c d Lewis, M; Bromley, K; Sutton, CJ; McCray, G; Myers, HL; Lancaster, GA (2021-02-03). "Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back!". Pilot and Feasibility Studies. 7: 40. doi:10.1186/s40814-021-00770-x. PMC 7856754. PMID 33536076.
  3. ^ Billé, R. (2010) “Action without change? On the use and usefulness of pilot experiments in environmental management.”. S.A.P.I.EN.S. 3 (1)
  4. ^ Sandra M Eldridge, Gillian A Lancaster, Michael J Campbell, Lehana Thabane, Sally Hopewell, Claire L Coleman, Christine M Bond. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS ONE. 2016; 11(3)
  5. ^ "The drug development process: Step 3: Clinical research". US Food and Drug Administration. 4 January 2018. Retrieved 29 March 2021.
  6. ^ Sandra M Eldridge, Claire L Chan, Michael J Campbell, Christine M Bond, Sally Hopewell, Lehana Thabane, Gillian A Lancaster on behalf of the PAFS consensus group. Consort 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016; 355: i5239