Increasing Efficiency of Oncology POC Studies Using Bayesian Adaptive Approach

• Activity Number: 164 - FDA Adaptive Designs and Master Protocols Guidance for Clinical Trials – Reflection and Outlook
• Type: Topic Contributed
• Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Rong Liu*
• Companies: Celgene Co.
• Keywords: Bayesian ; proof of concept ; oncology

Abstract

A key decision point on oncology drug development pathway is the proof of concept (POC) study. These POC studies need to provide information to the project teams to enable reasonable decision making about further developing a drug candidate. With increased costs of drug development, efficient studies for the POC study has become critical. However, resources allocated to POC are generally very limited and sample size are much smaller compared to confirmatory trial. Bayesian Approach can enhance the efficiency of the design and data analysis.