Conclusions
The accessibility of more rigorous mechanisms for capturing DLT data directly from patients has led to an increasing interest in integrating PROs into early-phase trials to better define treatment tolerability [The growth of novel methods in early-phase dose-finding has been rapid in the last decade, yet execution of innovative designs remain uncommon [Software in the form of an R Shiny web application for both simulation of design operating characteristics and direct protocol implementation of the method is available at 