The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?

Jonathan Alistair Cook; David John Beard; Johanna Rosemary Cook; Graeme Stewart MacLennan

doi:10.1186/s40814-016-0113-8

The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?

Jonathan Alistair Cook, David John Beard, Johanna Rosemary Cook, Graeme Stewart MacLennan

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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.

Original language	English
Article number	73
Journal	Pilot & Feasibility Studies
Volume	2
DOIs	https://doi.org/10.1186/s40814-016-0113-8
Publication status	Published - 13 Dec 2016

Keywords

Randomised trial
Pilot study
Recruitment
Monitoring
Multicentre
Feasibility

Access to Document

10.1186/s40814-016-0113-8Licence: CC BY

The curious case of an internal pilot in a multicentre randomised trial—time for a rethink?
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Cite this

@article{88217257c9f04240a91cb1c7c8f06453,

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.",

keywords = "Randomised trial, Pilot study, Recruitment, Monitoring, Multicentre, Feasibility",

author = "Cook, {Jonathan Alistair} and Beard, {David John} and Cook, {Johanna Rosemary} and MacLennan, {Graeme Stewart}",

note = "Acknowledgements The authors would like to acknowledge helpful discussions on this topic held with various colleagues in connection with a variety of projects. Funding No funding was received for this work.",

year = "2016",

month = dec,

day = "13",

doi = "10.1186/s40814-016-0113-8",

language = "English",

volume = "2",

journal = "Pilot & Feasibility Studies",