Early phase trials are recognised to have a major impact on later phase confirmatory trials. This course presents state of the art methodology for Phase I dose-escalation studies that are delivered via a mixture of lectures, practical sessions, and discussions.

The topics will include:
•    Model-based and model-free Phase I dose-escalation single-agent designs;
•    Phase I designs for dual-agent and dose-schedules trials
•    Phase I/II designs for molecularly targeted agents;
•    Randomised dose-escalations trials;
•    Inclusion of covariates into Phase I dose-escalation;

Among other methods we will learn about model-based dose-escalation in-patients studies (such as Continual Reassessment Method [CRM], Bayesian logistic regression model [BLRM], Escalation with Overdose Control [EWOC]), model-free and model-assisted designs, their extensions for dual-agent and dose-schedule trials, and implementation of these designs in a software (specifically, R).

Dates
Monday 24th of June – Wednesday 26th of June (three full day)

University of Cambridge Students and Staff, whose department will be covering the participation cost, please contact Admin Team at [email protected] to arrange an internal crosscharge and obtain an access passcode to use this booking system. PO number and Access Passcode is required during the booking process.