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-finding and dose-optimisation 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-finding single-agent designs;
•    Dose-optimisation strategies
•    Phase I dose-findings designs for dual-agent and dose-schedules trials
•    Phase I/II designs for cytotoxic drugs;
•    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).

The course focuses on in-person dose-finding studies and will cover several therapeutic areas, including oncology, infectious diseases, cardiovascular diseases, and opioids detoxification. 

University of Cambridge Students and Staff, whose department will be covering the participation cost, please raise a Purchase Order (or contact a member of your department who can assist with this) and send a PDF of the Purchase Order to sharon.dippenaar@mrc-bsu.cam.ac.uk.  You will then be sent the passcode which you will need to use along with the Purchase Order number to complete registration below, selecting the 'UoC Student/Staff Registration' option.