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

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 pragmati...

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Main Authors: Cook, J, Beard, D, MacLennan, G
Format: Journal article
Jezik:English
Izdano: BioMed Central 2016
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author Cook, J
Beard, D
Cook, J
MacLennan, G
author_facet Cook, J
Beard, D
Cook, J
MacLennan, G
author_sort Cook, J
collection OXFORD
description 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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spelling oxford-uuid:5f94c567-a27d-415e-8e1f-4aecd3a5e47b2022-03-26T17:47:50ZThe curious case of an internal pilot in a multicentre randomised trial-time for a rethink?Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:5f94c567-a27d-415e-8e1f-4aecd3a5e47bEnglishSymplectic Elements at OxfordBioMed Central2016Cook, JBeard, DCook, JMacLennan, GMulticentre 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.
spellingShingle Cook, J
Beard, D
Cook, J
MacLennan, G
The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
title The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
title_full The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
title_fullStr The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
title_full_unstemmed The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
title_short The curious case of an internal pilot in a multicentre randomised trial-time for a rethink?
title_sort curious case of an internal pilot in a multicentre randomised trial time for a rethink
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