All Times EDT
Keywords: combination therapy, oncology
Cancer research and drug development has experienced a shift in paradigm with combination therapies coming to the forefront over the last decade. In parallel, the mode of actions of the new chemical entities are diverse than ever, which presents unique challenges and opportunities. In this talk, the need for tailored approaches for selection of endpoints and analyses techniques depending on the primary objective of the trial (dose determination, characterization of population, proof of mechanism, proof of preliminary evidence of clinical efficacy, etc) will be emphasized. Statistical considerations for simulating likely signal (safety as well as efficacy) of combination therapy based on available single agent data (patient level as well as summary) will be discussed, which can be used to evaluate the contribution of components. Lastly, with basket trials and platform trials (with common backbone) becoming increasingly common and necessary in the development of combination therapies, available statistical methods that appropriately use data from multiple arms to improve precision of estimates will be discussed.