Navigating FDA’s expectations for drug approval: Adaptive designs for dose optimization and accelerated approval
Join us on Thursday, December 12th | 5:00 PM CET | 11:00 AM EST
IDDI is pleased to invite you to a webinar on the important aspects of Project Optimus and accelerated approval with a focus on statistical methods and adaptive trials.
ABSTRACT
The Oncology Center of Excellence (OCE) initiative, Project Optimus1 and its related FDA Draft Guidance 2 emphasize the shift from finding the maximum tolerated dose to the biological optimal dose for non-cytotoxic oncology therapeutic products.
This approach requires more data, and oncology drug developers will need to focus on meeting expectations for dose optimization prior to achieving drug approval. Randomization to different doses is key and allows for dose optimization in a registrational Phase 2/3 trial, potentially with the aim of accelerated approval.
1. https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
2. U.S. Department of Health and Human Services Food and Drug Administration, Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases, January 2023: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases
KEY TAKEWAYS
During this webinar we will present:
- An overview of important aspects of Project Optimus and accelerated approval with a focus on statistical methods and adaptive trials, including model‑based and model-assisted dose escalation designs, adaptive designs for dropping a dose arm at interim, and
- Phase 2/3 trials testing both an early and late endpoint for accelerated and full approval, respectively.
- The role of group sequential designs and sample size reassessment when designing registrational trials without good information on treatment effectiveness
SPEAKERS
- Elisabeth (Els) Coart, PhD: Director Statistical Consulting & Research, IDDI
- Vincent Staggs, PhD: Senior Scientist, IDDI
- Leandro Garcia Barrado, PhD: Research Biostatistician, IDDI
- Vaiva Deltuvaite-Thomas, PhD: Senior Scientist, IDDI