An Application of the Adaptive Bayesian Design for the Delayed Outcomes in a Phase II Clinical Trial

• Activity Number: 441
• Type: Contributed
• Date/Time: Tuesday, August 2, 2016 : 2:00 PM to 3:50 PM
• Sponsor: Section on Bayesian Statistical Science
• Author(s): Lei Feng* and Steven H. Lin and Suyu Liu
• Companies: MD Anderson Cancer Center and MD Anderson Cancer Center and MD Anderson Cancer Center
• Keywords: adaptive Bayesian design ; monitor delayed outcome ; interim monitoring ; application of Bayesian design ;

Abstract

This is a randomized phase II trial to assess the safety and efficacy of radiation therapy plus immunotherapy for patients with relapsed non-small cell lung cancer. The interim monitoring of toxicity is required to ensure the patient safety during the study. Routine monitoring methods can't be applied for the delayed toxicity outcome. We applied a Bayesian method developed by Cai, Liu, and Yuan (2014), where we treated the delayed toxicities as missing data and handled them using a multiple imputation approach. By simulations the proposed design yields desirable operating characteristics under various settings and dramatically reduces the trial duration.