Novel Bayesian Adaptive Designs and Their Applications in Cancer Clinical Trials, Séminaire par J. Jack Lee le 21 juin à 14h00
Clinical trial is a prescribed learning process for identifying safe and effective treatments. In recent years, rapid advancements in cancer biology, immunology, genomics, and treatment development demand innovative methods to identify better therapies for the most appropriate population in a timely, efficient, accurate, and cost-effective way. In my talk, I will first illustrate the concept of Bayesian update and Bayesian inference, a superior alternative to the traditional frequentist approach. Bayesian methods take the “learn as we go” approach and are innately suitable for clinical trials. Then, I will give an overview of Bayesian adaptive designs in the areas of adaptive dose finding, posterior probability and predictive probability calculation, outcome adaptive randomization, multi-endpoint phase II design, multi-arm platform design, and hierarchical modeling, etc.
Particularly, a new class of model-assisted designs will be introduced. Model-assisted designs combine the transparency and simplicity of the conventional algorithm-based designs with the superiority and rigorousness of model-based designs. They enjoy the superior performance comparable to more complicated, model-based designs, but can be implemented as simple as the conventional designs. Examples of the Bayesian optimal interval (BOIN) design, the keyboard design, the time-to-event BOIN (TITE-BOIN), the BOIN combination design, and the Bayesian Optimal Phase 2 (BOP2) design will be discussed. Real applications including BATTLE trial in lung cancer, ISPY 2 trial in breast cancer, and GBM AGILE in glioblastoma will be given. Bayesian adaptive clinical trial designs increase the study efficiency, allow more flexible trial conduct, and treat more patients with more effective treatments in the trial but also possess desirable frequentist properties.
Software tools including downloadable programs and online Shiny applications for the design and conduct of clinical trials can be found at:
https://biostatistics.mdanderson.org/SoftwareDownload/ and http://trialdesign.org/.