Feasibility & Pilot Work

A crucial part in the development of any intervention and trial is the preliminary work carried out before committing to a large-scale randomised controlled trial. Feasibility studies are used to estimate important parameters that are needed to design the main study, for example; willingness of patients to be randomised and enrolled in the study, motivation of clinicians to actively recruit participants, number of eligible people available, response rates and adherence/compliance rates. These studies may not necessarily lead on to further work; their aim is to assess whether a full-scale trial is possible. Feasibility work differs from pilot studies; a pilot study is a miniature version of the main trial, which allows trialists to determine whether the components of the main trial can all work together. Pilot work ensures that mechanisms of recruitment, randomisation, follow-up etc are able to run smoothly, if the mechanics do not run as expected than any issues can be corrected before the main trial begins.