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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.

Modelling cost-effectiveness and value of information in clinical trials to inform stop go decisions: results from the arctic study