Abstract
Methods The ARCTIC trial randomised patients with previously untreated Chronic Lymphocytic Leukaemia to receive fludarabine, cyclophosphamide, mitoxantrone and low dose rituximab (FCM-miniR) or fludarabine, cyclophosphamide and rituximab (FCR; standard care). An interim efficacy analysis was conducted after 103 patients had completed therapy. CEA and VOIA were conducted using a Markov decision model, based on subsequent data from 200 patients.
Highlights
Trial interim analyses are traditionally based on an assessment of efficacy and safety
To assess the potential utility of early cost-effectiveness analysis (CEA) and value of information analysis (VOIA) within the context of a randomised clinical trial
An interim efficacy analysis was conducted after 103 patients had completed therapy
Summary
Trial interim analyses are traditionally based on an assessment of efficacy and safety. Modelling cost-effectiveness and value of information in clinical trials to inform stop go decisions: results from the arctic study Alison Smith1*, Peter Hall2, John O’Dwyer1, Claire Hulme1, Dena Cohen1, Walter Gregory1 From 3rd International Clinical Trials Methodology Conference Glasgow, UK.
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