Currently, Phase I designs use the presence of Dose Limiting Toxicities (DLT) to guide dose escalation and de-escalation. The assumption is that this DLT outcome is observed without error. This presentation will illustrate the impact of toxicity attribution errors on Phase I designs and the recommended Phase II dose, and discuss the statistical and clinical implications of misclassification errors (false DLTs). Potential solutions to the problem will also be presented.
This program is for the research community.