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

University of Oxford

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

12 Downloads (Pure)

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

Bibliographical 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.

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?
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 353 KBLicence: CC BY

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",