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A trial like ALIC4E: why design a platform, response-adaptive, open, randomised controlled trial of antivirals for influenza-like illness?

A trial like ALIC4E: why design a platform, response-adaptive, open, randomised controlled trial of antivirals for influenza-like illness?
A trial like ALIC4E: why design a platform, response-adaptive, open, randomised controlled trial of antivirals for influenza-like illness?
ALIC4E is the first publicly funded, multicountry, pragmatic study determining whether antivirals should be routinely prescribed for influenza-like illness in primary care. The trial aims to go beyond determining the average treatment effect in a population to determining effects in patients with combinations of participant characteristics (age, symptom duration, illness severity, and comorbidities). It is one of the first platform, response-adaptive, open trial designs implemented in primary care, and this article aims to provide an accessible description of key aspects of the study design. 1) The platform design allows the study to remain relevant to evolving circumstances, with the ability to add treatment arms. 2) Response adaptation allows the proportion of participants with key characteristics allocated to study arms to be altered during the course of the trial according to emerging outcome data, so that participants' information will be most useful, and increasing their chances of receiving the trial intervention that will be most effective for them. 3) Because the possibility of taking placebos influences participant expectations about their treatment, and determining effects of the interventions on patient help seeking and adherence behaviour in real-world care is critical to estimates of cost-effectiveness, ALIC4E is an open-label trial.
2312-0541
1-6
Butler, Christopher C.
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Coenen, Samuel
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Saville, Benjamin R.
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Cook, Johanna
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Velden, Alike van der
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Homes, Jane
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Jong, Menno de
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Little, Paul
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Goossesns, Herman
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Beutles, Philipe
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Ieven, Greet
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Francis, Nicholas
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Moons, Pieter
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Bongard, Emily
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Verheij, Theo
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Butler, Christopher C.
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Coenen, Samuel
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Saville, Benjamin R.
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Cook, Johanna
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Velden, Alike van der
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Homes, Jane
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Jong, Menno de
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Little, Paul
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Goossesns, Herman
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Beutles, Philipe
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Ieven, Greet
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Francis, Nicholas
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Moons, Pieter
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Bongard, Emily
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Verheij, Theo
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Butler, Christopher C., Coenen, Samuel, Saville, Benjamin R., Cook, Johanna, Velden, Alike van der, Homes, Jane, Jong, Menno de, Little, Paul, Goossesns, Herman, Beutles, Philipe, Ieven, Greet, Francis, Nicholas, Moons, Pieter, Bongard, Emily and Verheij, Theo (2018) A trial like ALIC4E: why design a platform, response-adaptive, open, randomised controlled trial of antivirals for influenza-like illness? ERJ Open Research, 4 (2), 1-6, [00046]. (doi:10.1183/23120541.00046-2018).

Record type: Article

Abstract

ALIC4E is the first publicly funded, multicountry, pragmatic study determining whether antivirals should be routinely prescribed for influenza-like illness in primary care. The trial aims to go beyond determining the average treatment effect in a population to determining effects in patients with combinations of participant characteristics (age, symptom duration, illness severity, and comorbidities). It is one of the first platform, response-adaptive, open trial designs implemented in primary care, and this article aims to provide an accessible description of key aspects of the study design. 1) The platform design allows the study to remain relevant to evolving circumstances, with the ability to add treatment arms. 2) Response adaptation allows the proportion of participants with key characteristics allocated to study arms to be altered during the course of the trial according to emerging outcome data, so that participants' information will be most useful, and increasing their chances of receiving the trial intervention that will be most effective for them. 3) Because the possibility of taking placebos influences participant expectations about their treatment, and determining effects of the interventions on patient help seeking and adherence behaviour in real-world care is critical to estimates of cost-effectiveness, ALIC4E is an open-label trial.

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00046-2018.full - Version of Record
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Accepted/In Press date: 16 April 2018
Published date: 1 May 2018

Identifiers

Local EPrints ID: 435421
URI: http://eprints.soton.ac.uk/id/eprint/435421
ISSN: 2312-0541
PURE UUID: 2f1b3bfd-d59e-418d-bcfe-61da2b3c06fa
ORCID for Nicholas Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 06 Nov 2019 17:30
Last modified: 16 May 2020 01:02

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Contributors

Author: Christopher C. Butler
Author: Samuel Coenen
Author: Benjamin R. Saville
Author: Johanna Cook
Author: Alike van der Velden
Author: Jane Homes
Author: Menno de Jong
Author: Paul Little
Author: Herman Goossesns
Author: Philipe Beutles
Author: Greet Ieven
Author: Pieter Moons
Author: Emily Bongard
Author: Theo Verheij

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