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In the design of cancer clinical trials, one is often concerned with a number of options in the event that several treatments are of interest. Methods: We explore in this work the distinct possibilities when four treatments are available, one acting as control and three as potentially efficacious alternatives. This design may be embedded within the context of multi-arm multi-stage (MAMS) trials where one may select a twoor three-stage design. Potential Results: We explore the application of such designs, including trade-offs between potential gains in the number of patients with additional stages contrasted with patients “lost” due to practical considerations such as patients randomised in dropped arms while waiting for interim analyses and inspection by an Independent Data and Safety Committee. In addition, in cancer studies one may focus on the primary end-point using a time-to-event analysis or a binary outcome by looking at the probability of (potentially progression-free) survival at a specific, clinically meaningful, time point. The effect of such choices is extensively investigated. Potential Relevance & Impact: We conclude with a discussion of the available software for MAMS designs and their advantages and disadvantages in terms of accuracy.

Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)