Improving early phase oncology clinical trial design: An opportunity for statisticians

Abstract

This short communication supports that rule-based study designs such as the '3 + 3' study design are still being used in early phase oncology development programs despite their inferior performance to model-based and model-assisted designs. Statisticians have an opportunity to shape and improve early phase oncology drug development programs by introducing newer, more efficient study designs that estimate the Optimal Biological dose to their oncology trialist colleges.