Bayesian Dose Escalation Study Design with Consideration of Both Early and Late Onset Toxicity

Abstract

In phase I oncology trials, dose-limiting toxicity (DLT) is often used as the endpoint during early cycles in dose escalation studies to find the maximum tolerated dose (MTD). Bayesian adaptive designs such as the Escalation with Overdose Control (EWOC; Babb et al., Stat Med 17:1103–1120, 1998) methods have been introduced to protect patients from overdosing and account for variability in toxicity estimates.