The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not
Abstract
Feasibility and pilot studies play an important role in the preliminary planning of a proposed full-size randomized clinical trial (RCT). In essence, feasibility studies are used to help develop trial interventions or outcome measures, whereas pilot studies replicate, in miniature, a planned full-size RCT. However, the terms used for these preliminary studies are sometimes considered synonymous, and in practice may overlap considerably or be combined. The important issue is not the distinction between these: the important distinction is between such preliminary studies and a proper RCT. J Orthop Sports Phys Ther 2014;44(8):555–558. doi:10.2519/jospt.2014.0110
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A sample size of 40 (20 in each treatment arm) was estimated to be sufficient to adequately evaluate the feasibility of undertaking a full clinical trial.
“Based on guidance in the literature,47 the research team estimated that a sample size of 40 (20 in each treatment arm) would be sufficient to adequately evaluate the feasibility of undertaking a full clinical trial.31”
These are feasibility problems that would have been revealed in a preliminary feasibility study.
“These are feasibility problems that would have been revealed in a preliminary feasibility study.47”
Conducting a feasibility study is an important step before conducting a full clinical trial, especially in a setting where a high-quality clinical trial has never been conducted.
“Conducting a feasibility study is an important step before conducting a full clinical trial,47 especially in a setting where a high-quality clinical trial has never been conducted, which lacks recommendations from previous experiences for such a study.”
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Dang, T. H., Wickramasinghe, N., Jayaraman, P. P., Burbury, K., Alexander, M., Whitechurch, A., Dyer, M., Quinn, S., Forkan, A. R. M., & Schofield, P. (2025) · JMIR Formative Research · doi:10.2196/65302 · Cited by 9 · see citing works
Ross, R. E., VanDerwerker, C. J., George, M. S., & Gregory, C. M. (2023) · Topics in Stroke Rehabilitation · doi:10.1080/10749357.2023.2165258 · Cited by 9 · see citing works
Importancia del Estudio Piloto en un Proyecto de Intervención
Sánchez, H. F., Facundo, F. R. G., Herrera-Medina, D., & Sidani, S. (2020) · Index de Enfermería · doi:10.58807/indexenferm20233776 · Cited by 9 · see citing works
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Howell, D. R., Seehusen, C. N., Walker, G. A., Reinking, S. E., & Wilson, J. C. (2021) · Physical Therapy in Sport · doi:10.1016/j.ptsp.2021.05.014 · Cited by 8 · see citing works
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Pilot Study of the MAP Curriculum for Psychotherapy Competencies in Child and Adolescent Psychiatry
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Distinctive aspects of consent in pilot and feasibility studies
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Validity and Reliability Testing of the Adapted Foreign Language Classroom Anxiety Scale (FLCAS)
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- Authors
- Abbott, J. H.
- Corresponding author
- Abbott, J. Haxby
- ORCID
- Abbott, J. Haxby
- Venue
- Journal of Orthopaedic & Sports Physical Therapy
- Published
- 2014-08
- Volume
- 44
- Issue
- 8
- Pages
- 555-558
- ISSN
- 0190-6011 (ISSN-L)
- 1938-1344
- OpenAlex
- W2064386551
- Cited by
- 204
- References
- 13
- Citations by year
- 2026: 14 · 2025: 23 · 2024: 20 · 2023: 22 · 2022: 29 · 2021: 28 · 2020: 18 · 2019: 17 · 2018: 6 · 2017: 12 · 2016: 7 · 2015: 6
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Orthopaedic and Sports Physical Therapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Health Professions › Health Information Management › Methodologies in Health Research and Practice
- Keywords
- randomized controlled trials, feasibility study, pilot study, trial design, intervention development, outcome measures
- MeSH terms
- Feasibility Studies, Humans, Terminology as Topic, Pilot Projects, Randomized Controlled Trials as Topic
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