We examine several variance estimators for cumulative incidence estimators that have been proposed over time, some of which are derived from asymptotic martingale or counting process theory, and some of which are developed from the moments of the multinomial distribution. There is little...

We propose a phase I clinical trial design that seeks to determine the cumulative safety of a series of administrations of a fixed dose of an investigational agent. In contrast with traditional phase I trials that are designed solely to find the maximum tolerated dose of the agent, our design...

Phase I clinical trials are designed to study several doses of the same drug in a small group of patients to determine the maximum tolerated dose (MTD), which is defined as the dose that is associated with dose-limiting toxicity (DLT) in a desired fraction Γ of patients. Durham and Flournoy [5]...