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A '''pilot study''', '''pilot project''', '''pilot test''', or '''pilot experiment''' is a small scale preliminary study conducted in order to evaluate [[Feasibility study|feasibility]], [[Time|duration]], [[cost]], adverse events, and improve upon the study design prior to performance of a full-scale [[research project]].<ref name="thabane">{{cite journal |pmid=20053272|journal=BMC Med Res Methodol|year=2010|volume=10|issue=1|pages=1|doi=10.1186/1471-2288-10-1|title=A tutorial on pilot studies: the what, why and how|vauthors=Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH|pmc=2824145}}</ref>
A '''pilot study''', '''pilot project''', '''pilot test''', or '''pilot experiment''' is a small-scale preliminary study conducted to evaluate [[Feasibility study|feasibility]], [[Time|duration]], [[cost]], [[adverse event]]s, and improve upon the study design prior to performance of a full-scale [[research project]].<ref name="thabane">{{cite journal |pmid=20053272|journal=BMC Med Res Methodol|year=2010|volume=10|issue=1|pages=1|doi=10.1186/1471-2288-10-1|title=A tutorial on pilot studies: the what, why and how|vauthors=Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH|pmc=2824145}}</ref><ref name="lewis">{{cite journal | last=Lewis | first=M | last2=Bromley | first2=K | last3=Sutton | first3=CJ | last4=McCray | first4=G | last5=Myers | first5=HL | last6=Lancaster | first6=GA | title=Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! | journal=Pilot and Feasibility Studies | volume=7 | date=2021-02-03 | pmid=33536076 | pmc=7856754 | doi=10.1186/s40814-021-00770-x | page=40}}</ref>


==Implementation==
==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.<ref name=thabane/> A pilot study is often used to test the design of the full-scale experiment which then can be adjusted.<ref name=thabane/> It is a potentially valuable insight and, should anything be missing in the pilot study, it can be added to the full-scale (and more expensive) experiment to improve the chances of a clear outcome.<ref name=thabane/>
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.<ref name=thabane/> A pilot study is used to formulate the design of the full-scale experiment which then can be adjusted.<ref name=thabane/><ref name=lewis/> 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 a test|power of testing the hypothesis of the study]].<ref name=lewis/> Analysis from the pilot experiment can be added to the full-scale (and more expensive) experiment to improve the chances of a clear outcome.<ref name=thabane/><ref name=lewis/>


==Applications==
==Other 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.<ref>[http://sapiens.revues.org/index979.html 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) ]</ref> [[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.<ref name=thabane/>
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.<ref>[http://sapiens.revues.org/index979.html 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) ]</ref> [[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.<ref name=thabane/>


In the health research context, 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.<ref name=thabane/> A feasibility study asks whether something can be done, should we proceed with it, 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 &ndash; or part of a future study &ndash; is conducted on a smaller scale.<ref name=thabane/><ref>[https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150205 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)]</ref>
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.<ref name=thabane/> 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,<ref name=thabane/><ref>[https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0150205 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)]</ref> which, if having produced positive results, may lead to a [[Phases of clinical research#Phase I|Phase I clinical trial]].<ref name="fda">{{cite web |title=The drug development process: Step 3: Clinical research |url=https://www.fda.gov/patients/drug-development-process/step-3-clinical-research |publisher=US Food and Drug Administration |access-date=29 March 2021 |date=4 January 2018}}</ref>


A checklist was published in 2016 to provide guidance on how to report pilot trials.<ref>[https://www.bmj.com/content/355/bmj.i5239 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]</ref>
A checklist was published in 2016 to provide guidance on how to report pilot trials.<ref>[https://www.bmj.com/content/355/bmj.i5239 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]</ref>

Revision as of 21:42, 29 March 2021

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

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] 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

References

  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.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  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.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  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