Statistical Approaches in the Development of Digital Therapeutics

This chapter provides an overview of challenges and opportunities for applying statistical thinking in digital therapeutics (DTx) product development. It deals with some background on different DTx solutions to prevent, treat, and manage medical conditions and diseases. The chapter describes three core disciplines for the DTx development: statistics, pharmacometrics, and data science, and discusses their potential for combination and synergy. It presents an “integrated scientific learning approach” that can be used to define the target characteristics of a new DTx product and develop a statistical strategy to build the clinical evidence base for the DTx product. The chapter explores an application of this approach in the context of a hypothetical development program of a novel mobile cognitive behavioral therapy for depression. Statistics is an essential discipline in the biopharmaceutical research and development enterprise.