To mark Clinical Trials Day 2026, Matt George, Senior Statistician, and Sam Hinsley, Statistics Manager at Phastar, highlight how statistical innovation is reshaping early-phase clinical trials in a comment for ACRP Clinical Researcher.
They discuss the growing complexity introduced by early-phase combination trials, where traditional approaches can lead to overly conservative or unsafe dose recommendations. By adopting data-driven methods, such as contour-based frameworks that allow new dose combinations to be introduced mid-trial, statisticians can improve precision, safety, and efficiency.
They also point to the work of the Early Phase Special Interest Group, which brings together experts from industry and academia to advance statistical methodologies and raise standards in early-phase research. Their message is clear: better statistical approaches at the earliest stages are key to ensuring the right treatments move forward.