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

Butler, Christopher C., Coenen, Samuel, Saville, Benjamin R., Cook, Johanna, van der Velden, Alike, Homes, Jane, de Jong, Menno, 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) , 00046-2018. 10.1183/23120541.00046-2018

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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.

Item Type: Article
Date Type: Published Online
Status: Published
Schools: Medicine
Publisher: European Respiratory Society
ISSN: 2312-0541
Funders: e European Commission FP7 (grant number 602525)
Date of First Compliant Deposit: 12 June 2018
Date of Acceptance: 16 April 2018
Last Modified: 13 Jun 2018 09:50
URI: http://orca.cf.ac.uk/id/eprint/112221

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