"Using the Continual Reassessment Method in Dose-Finding Phase I Trials"
September 15, 2009 @ 3:30 pm - 4:30 pm
Alexia Iasonos, Ph.D., Memorial-Sloan Kettering
Location: BRB - 251
TITLE: Using the Continual Reassessment Method in Dose-Finding Phase I Trials
An extensive literature has covered the statistical properties of the Continual Reassessment Method (CRM) and the modifications of this method. While there are some applications of CRM designs in recent Phase I trials, the standard method of escalating doses after 3 patients with an option for an additional 3 patients (SM) remains very popular, mainly due to its simplicity. From a practical perspective, clinicians are interested in designs that can estimate the maximum tolerated dose (MTD) with a smaller sample size and/or with shorter trial duration. In this talk, I will present simulations that compare CRM-based methods with the SM in terms of various clinical endpoints, such as accuracy, safety, trial duration, and sample size under different scenarios. CRM with a fixed or a varying sample approach with the implementation of a stopping rule will also be presented.