Untenable dosing: A common pitfall of modern DLT-targeting Phase I designs in oncology

There is increasing use of Phase I statistical designs to find a dose that causes rapidly emerging and particularly concerning severe or life-threatening toxicities (dose-limiting toxicities, DLTs) in a specified percent of patients most commonly 25%. While a convenient statistical framework, the foundation for selecting any specified target DLT rate, and its relevance to the recommended Phase II dose is generally lacking.We surveyed 78 medical...