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Do you have an idea for a large-scale, publicly funded randomised controlled trial (RCT)? Virtually all large public funding bodies now expect substantial work to have been done prior to them funding a large trial. Preliminary research suggests greater study feasibility and pilot data point to the potential for the investigators’ hypotheses to have merit. There is a new journal, Pilot and Feasibility Studies, which publishes the results of such studies. The purpose of this editorial is to encourage researchers to think about a pilot or feasibility study before the main trial and to publish the results.
Similar to a RCT, a pilot trial should have clear objectives, but in this case pertaining to feasibility and uncertainties in the main trial design, and a priori criteria for successful progression. It should be designed, conducted and reported using the same standards as any high-quality RCT. Pilot and feasibility studies are important in that they can ensure that scarce research money and researcher efforts are being invested in efficient trials that can provide definitive answers to important research questions. Guidelines for reporting pilot trials as part of an extension of the Consolidated Standards of Reporting Trials (CONSORT) statement have been published.1 2
A recent review of physical activity trials comments on some of the feasibility issues that are more common in this area.3 These include the challenge of blinding of group allocation, retaining interest of the comparison group, participant and instructor fidelity, and being able to recruit people who are not already …
Contributors MJC drafted the manuscript. MAM and GL suggested revisions. All authors read and approved the final manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests GL is the editor-in-chief of the journal Pilot and Feasibility Studies.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; internally peer reviewed.