medRxiv preprint

Accelerating Mental Health Precision Trial : An Effective Visualization-Driven Tool for Power and Sample Size Estimation in Biomarker-based Study Designs

Precision medicine has given rise to a spectrum of biomarker-guided trial designs, from simple enrichment and strategy designs to more complex adaptive frameworks. To address the need for user-friendly tools that span this spectrum, we developed a unified R Shiny platform that first implements three standard designs: the randomize-all design, the enrichment design, and the biomarker-strategy design, allowing researchers to perform power and sample size calculations under each framework with intuitive inputs and visual outputs. Building on this foundation, the platform further extends to support two-stage general randomized basket trial designs with interim analysis, which can be viewed as a

health informatics