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Abstract:
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East ESCALATE is a widely used tool for simulating and analyzing Phase 1 dose escalation trials. Single-agent designs in this module include the 3+3, the modified Toxicity Probability Interval (mTPI) method, the Continual Reassessment Method (CRM), and the Bayesian Logistic Regression Model (BLRM). Two new methods recently introduced in the software are for dual-agent designs: (1) an extension of the BLRM and (2) a product of independent beta probabilities escalation (PIPE) design.We'll begin by reviewing the underlying methodology of these new designs, and then present case studies using the software to inform the best choice of design parameters.
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