A FRIENDS OF CANCER RESEARCH WHITE PAPER
The article explores the complex landscape of determining optimal drug doses in early-phase oncology trials, with a focus on achieving a delicate balance between efficacy and safety. Traditionally centered on the maximum tolerated dose (MTD), contemporary therapies require a paradigm shift towards premarket dose optimization. Guided by Project Optimus, an initiative led by the FDA’s Oncology Center of Excellence, the article delves into the challenges of interpreting data from dose-finding studies and suggests leveraging emerging technologies. This exploration is essential to refine methodologies, enhance data collection, and ultimately ensure that patients receive effective and well-tolerated treatments in the evolving landscape of oncology drug development.