The Distinction Between Randomized Clinical Trials (RCTs) and Preliminary Feasibility and Pilot Studies: What They Are and Are Not

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