Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared a post on LinkedIn:
“Hot off the press in American Society of Clinical Oncology (ASCO) journal JCO oncology advances
Pleased to share our study “Impact of FDA Project Optimus Guidance on Design of Early-Phase Clinical Trials”
Analysis of 367 phase I oncology trials (2021-2024) reveals Project Optimus is transforming cancer drug development:
Bayesian designs surged 48% → 75%
30% now include dose-optimization plans
Moving beyond max tolerated dose approach
This shift toward smarter, more patient-centered trial design marks a pivotal moment in early-phase cancer research.”
Title: Impact of Food and Drug Administration Project Optimus Guidance on Design of Early-Phase Clinical Trials
Authors: Deepak Bhamidipati, Suzanne Jones, David Spigel, Gerald Falchook, Manish Patel, Howard Burris, Vivek Subbiah
Read the Full Article.
More from Vivek Subbiah on OncoDaily.