Every week, we select a recently published Open Access article to feature. This week’s article is from Pharmaceutical Statistics and investigates improving early phase oncology clinical trial design. 

The article’s abstract is given below, with the full article available to read here. 

Phillips, A, Mondal, S. Improving early phase oncology clinical trial design: An opportunity for statisticians. Pharmaceutical Statistics. 2022; 1– 4. doi:10.1002/pst.2287

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.