Key result
The authors propose discontinuing the terms 'internal' and 'external' pilot studies in favor of an alternative taxonomy that recognizes the routine refinement processes in multicentre randomized trials.
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Design
Editorial
The authors propose discontinuing the 'internal/external pilot study' terminology in favor of an alternative taxonomy and transparent reporting of trial refinement processes.
Multicentre randomised trials are complex projects with many operational uncertainties. The embedding of a formal check upon study progress and viability at a pre-specified time point (sometimes referred to as an 'internal pilot') is becoming increasingly common within multicentre pragmatic randomised trials. However, it is worth considering this practice. We argue that most, if not all, multicentre trials have reassessment of the recruitment strategy and study processes whilst the study is running. Additionally, we propose discontinuation of the 'internal/external pilot study' terminology. Instead, we suggest for an alternative taxonomy along with greater recognition of the process of refinement which routinely occurs in trials and transparent reporting of it.
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Cook et al. (2016) reported an editorial. The authors propose discontinuing the terms 'internal' and 'external' pilot studies in favor of an alternative taxonomy that recognizes the routine refinement processes in multicentre randomized trials.
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