title: The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
abstract: 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.
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Nuffield Orthopaedic Centre, University of Oxford, Windmill Road, Oxford, OX3 7LD UK.
authors.forename: Jonathan Alistair
authors.identifier: 0000-0002-4156-6989
authors.initials: JA
authors.lastname: Cook
authors.affiliation: Surgical Intervention Trials Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Nuffield Orthopaedic Centre, University of Oxford, Windmill Road, Oxford, OX3 7LD UK.
authors.forename: David John
authors.initials: DJ
authors.lastname: Beard
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG UK.
authors.forename: Johanna Rosemary
authors.initials: JR
authors.lastname: Cook
authors.affiliation: Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD UK.
authors.forename: Graeme Stewart
authors.initials: GS
authors.lastname: MacLennan
keywords: Feasibility; Monitoring; Multicentre; Pilot study; Randomised trial; Recruitment