QSU Research Methods Seminar - Statistical Designs for Phase I Cancer Clinical Trials
Phase I cancer clinical trials are the first human studies of new drugs or drug combinations. These trials are typically small, single arm, open-label, and sequential studies. A principal goal of such trials is to establish the recommended safe dose and dose schedule for phase II trials, which evaluate the drug efficacy. The guiding principle for dose escalation in these trials is to avoid unnecessary exposure of patients to both subtherapeutic and toxic doses. In this talk, I will review some frequentist and Bayesian statistical approaches, in particular models using monotonic relationship between dose and toxicity rate. I will also discuss the extension of such models to drug combination trials.
Contact: Linda Enomoto | 650-723-5096 | email@example.com
- Ying Lu, PhD Professor, HRP - Biostatistics