Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared a post on X:
“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.
Medical Oncologists like Neeraj Agarwal, Presidential Endowed Chair of Cancer Research at the Huntsman Cancer Institute (HCI), and Gustavo Gössling, Affiliate Member of Sociedade Brasileira de Oncologia Clínica – SBOC, congratulated Dr. Vivek Subbiah and team for their impactful JCO Oncology Advances publication – highlighting how FDA’s Project Optimus is transforming early-phase oncology trials.
Quoting Neeraj Agarwal‘s post:
“Congrats Vivek Subbiah and team on their important study in JCO Oncology Advances how FDA Project Optimus is transforming early-phase oncology trials – shifting focus from “maximum tolerated dose” to smarter, patient-centered designs huge step forward for cancer research!”
Quoting Gustavo Gössling‘s post:
“Bayesian Designs such as BOIN surpassed 3+3 as the most frequent phase I design. An overall trend towards the adoption of faster, safer, smarter and more patient-centric designs, following FDA Project Optimus. Great for both patients and scientific community!”
More from Vivek Subbiah on OncoDaily.