All Times EDT
Keywords: 3x3 design, Continual reassessment method, Bayesian paradigm
Very often, phase I Oncology trials involve a search for the maximum tolerated dose. The 3x3 design is considered the workhorse for such trials, but it is also blamed to be simplistic for not using all available data at each step. Continual reassessment methods have been developed based on a Bayesian paradigm, yet they are quite hard to implement (especially in multi-center settings). I would like to stimulate a discussion about the dilemma that a sponsor encounters when they plan their Phase I trials of cytotoxic or cytostatic therapy.