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Treating patients with novel biological agents is becoming a leading trend in oncology. Unlike cytotoxic agents, for which efficacy and toxicity monotonically increase with dose, biological agents may exhibit non‐monotonic patterns in their dose–response relationships. Using a trial with two biological agents as an example, we propose a dose finding design to identify the biologically optimal dose...
A Bayesian model and design are described for a phase I–II trial to optimize jointly the doses of a targeted agent and a chemotherapy agent for solid tumours. A challenge in designing the trial was that both the efficacy and the toxicity outcomes were defined as four‐level ordinal variables. To reflect possibly complex joint effects of the two doses on each of the two outcomes, for each marginal distribution...
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...
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