Sam Hinsley, Statistics Manager at Phastar, shares practical insights into early phase clinical trial design in a new article for Biopharm International. The piece explores the evolving statistical approaches shaping modern drug development.
She examines how Phase I trials are moving beyond the traditional focus on maximum tolerated dose (MTD) toward identifying optimal biological dose (OBD), the growing role of model-based and model-assisted designs, and the impact of regulatory initiatives such as Project Optimus on dose optimization strategies.
”In an evolving landscape of early phase drug development, sponsors need flexible yet robust statistical approaches to ensure promising compounds are evaluated effectively and efficiently. Getting this stage right offers the opportunity to not only accelerate timelines but also maximize the chances of bringing safe, effective treatments to patients.”