Pilot Clinical Study

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A Pilot Clinical Study is a small-scale clinical study that replicate, in miniature, a planned full-size RCT.



References

2019

  • https://www.news-medical.net/health/What-are-Pilot-Studies-and-Clinical-Trials.aspx#2
    • QUOTE: ... A pilot study is a small-scale study conducted in preparation for a larger investigation. The purpose of a pilot study is to increase the likelihood of a successful future RCT by exploring the efficiency, internal validity and fundamentally, the delivery of proposed trials. To be most effective, they should test the logistics of the proposed study methods under similar circumstances to the planned trial. Pilot studies should test key elements of the trial, including recruitment and retention strategies, intervention delivery, data collection methods and adherence to the study protocol. In addition to informing researchers about the feasibility of their future RCT, they play an important role in the eventual implementation and dissemination of the intervention under study by identifying barriers and facilitators. ...

2014

  • (Abbott, 2014) ⇒ J. Haxby Abbott. (2014). “The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not.” In: Journal of Orthopaedic & Sports Physical Therapy, 44(8).
    • ABSTRACT: Feasibility and pilot studioes 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.