AI in the Trial Analysis: Interfacing with Regulatory Guidance

In this note we discuss three such uses of AI in the analysis of clinical trials. In each, a model is used to produce data that participates directly in treatment effect estimates. One is adding power to the analysis of randomized controlled trials (RCTs), another is enabling a reduced sample size in RCTs, and the last is supporting single arm trials. We review these applications, the regulatory considerations for use in studies, and look ahead to future growth of AI in drug development.