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A small n, sequential, multiple‐assignment, randomized trial (called ‘snSMART’) is a small sample multistage design where participants may be rerandomized to treatment on the basis of intermediate end points. This design is motivated by the ‘A randomized multicenter study for isolated skin vasculitis’ trial (NCT02939573): an on‐going snSMART design focusing on the evaluation of three drugs for isolated...
The use of the continual reassessment method (CRM) and other model‐based approaches to design Phase I clinical trials has increased owing to the ability of the CRM to identify the maximum tolerated dose better than the 3 + 3 method. However, the CRM can be sensitive to the variance selected for the prior distribution of the model parameter, especially when a small number of patients are enrolled....
Summary We propose a hierarchical model for the probability of dose‐limiting toxicity (DLT) for combinations of doses of two therapeutic agents. We apply this model to an adaptive Bayesian trial algorithm whose goal is to identify combinations with DLT rates close to a prespecified target rate. We describe methods for generating prior distributions for the parameters in our model from a basic set...
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