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In many phase II trials in solid tumours, patients are assessed usingendpoints based on the Response Evaluation Criteria in Solid Tumours (RECIST)scale. Often, analyses are based on the response rate. This is the proportionof patients who have an observed tumour shrinkage above a pre-defined level andno new tumour lesions. The augmented binary method has been proposed to improvethe precision of the estimator of the response rate. The method involvesmodelling the tumour shrinkage to avoid dichotomising it. However, in manytrials the best observed response is used as the primary outcome. In suchtrials, patients are followed until progression, and their best observed RECISToutcome is used as the primary endpoint. In this paper, we propose a methodthat extends the augmented binary method so that it can be used when theoutcome is best observed response. We show through simulated data and data froma real phase II cancer trial that this method improves power in both single-armand randomised trials. The average gain in power compared to the traditionalanalysis is equivalent to approximately a 35% increase in sample size. Amodified version of the method is proposed to reduce the computational effortrequired. We show this modified method maintains much of the efficiencyadvantages.

Improving phase II oncology trials using best observed RECIST response as an endpoint by modelling continuous tumour measurements