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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
Abstract #307286
Title: Increasing Efficiency of Oncology POC Studies Using Bayesian Adaptive Approach
Author(s): Rong Liu*
Companies: Celgene Co.
Keywords: Bayesian ; proof of concept ; oncology

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.

Authors who are presenting talks have a * after their name.

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