Navigating the Complexities of Adaptive Platform Trials: Design and Simulation

Music City Center 

As clinical trial design evolves to encompass innovative methodologies like Bayesian adaptive designs and master protocols, the complexity and variety of design options can be overwhelming. This presentation will delve into the intricacies of designing and simulating adaptive platform trials, highlighting the pivotal role of statisticians in this new landscape.

Building on a platform trial currently under design, this talk will illustrate how the role of statisticians has evolved from traditional data analysis to key contributors in the trial design process. As design complexity increases, extensive simulations become a necessity, opening up opportunities for statisticians to guide the design process.

This presentation will provide a brief overview of adaptive platform trials, including their terminology, potential risks and benefits. It will demonstrate how simulations are conducted using OCTOPUS, combined with trial-specific additions, to accommodate various options explored for Bayesian analysis. It will present several visualizations used to illustrate trade-offs and evaluate the frequentist operating characteristics of a Bayesian design.

The focus will be on how intuitive visuals and advanced simulation tools can guide the team and stakeholders to understand the trial processes and expected outcomes under a wide range of scenarios. This approach facilitates informed decision-making and optimizes trial design to potentially save time, resources, and most importantly, enhance patient outcomes.

platform trials