Novel Bayesian Adaptive Designs and Their Software Implementation for Phase I Clinical Trials with Late-Onset Toxicity

• Activity Number: 584 - Innovations and Breakthroughs in Oncology Dose Finding Designs for Time-to-Event Monitoring and Trial Acceleration in the New Age of Immunotherapy and Cell Therapy
• Type: Topic Contributed
• Date/Time: Thursday, August 6, 2020 : 3:00 PM to 4:50 PM
• Sponsor: Section on Risk Analysis
• Author(s): Yanhong Zhou* and J. Jack Lee and Ying Yuan
• Companies: MD Anderson Cancer Center and MD Anderson Cancer Center and The University of Texas MD Anderson Cancer Center
• Keywords: Phase I; Late-onset toxicity; model-assisted design; targeted therapy ; immunotherapy

Abstract

In the era of molecularly targeted therapy and immunotherapy, one common issue in phase I clinical trials is late-onset toxicity. A number of novel Bayesian adaptive designs have been proposed to address this issue, including model-based designs such as the time-to-event continual reassessment method (TITE-CRM), and model-assisted designs such as the time-to-event Bayesian optimal interval design (TITE-BOIN) and time-to-event keyboard (TITE-keyboard) design. In this talk, we will focus on TITE-BOIN and TITE-keyboard designs because of their simplicity and superior performance. We will describe the methodology of these designs and their software implementation using Shiny. We will use real-world examples to demonstrate the use of the online Shiny app to design phase I trials with late-onset toxicity. The Shiny app is freely available at www.trialdesign.org.