Statistics in medicine
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Statistics in medicine · Oct 2009
Comparative StudyA comparison of model choices for the Continual Reassessment Method in phase I cancer trials.
Determination of the maximum tolerated dose (MTD) is the main objective of phase I trials. Trials are typically carried out with restricted sample sizes. Model-based approaches proposed to identify the MTD (including the Continual Reassessment Method or CRM) suppose a simple model for the dose-toxicity relation. ⋯ We show that average performances of a one-parameter model are superior and that the power model has good operating characteristics. Some models can speed up dose escalation and lead to more aggressive designs. We derive some behavior related to the choice of model and insist on the use of simulations under several scenarios before the initiation of each new trial in order to determine the best model to be used.