A likelihood-based approach for computing the operating characteristics of the 3+3 phase I clinical trial design with extensions to other A plus B designs

摘要

Background In phase I clinical trials, the 3+3 algorithmic design has been unparalleled in its popularity. The statistical properties of the 3+3 design have been studied in the literature either in comparison with other methods or by deriving exact formulae of statistical quantities. However, there is still much to be known about its capabilities of describing and accounting for uncertainties in the observed data.