Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared a post on X:
“Hot off the press in ASCO, 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
Journal: JCO
Authors: Deepak Bhamidipati, Suzanne Jones, David Spigel, Gerald Falchook, Manish Patel, Howard Burris, and Vivek Subbiah
More from Vivek Subbiah on OncoDaily.