Clinical Trial Exploration (teal)

Clinical Trial Exploration is a portfolio project: an interactive exploratory review of CDISC ADaM data built with teal, the pharmaverse framework for clinical Shiny applications.

It uses the public CDISC pilot study (xanomeline vs. placebo in Alzheimer’s disease, safety population, n = 254) from the pharmaverseadam package. No sponsor or patient data is involved.

Features

• Demographics, SOC/PT adverse-event tables and lab trajectories by visit (ADSL, ADAE, ADLB)
• Custom teal module for subject-level AE signal screening: volcano plot of risk differences with Fisher tests and a ranked table
• Derived ADTTE endpoint (time to first dermatologic AE) with Kaplan–Meier curves and Cox hazard ratio
• One filter panel drives every module; Show R code reproduces each output from the raw ADaM data

Technical

Visits and baselines come from the ADaM flags (ABLFL, ANL01FL), not ad-hoc filters. Incidence is counted per subject with denominators from ADSL. The analysis logic sits in pure R functions with testthat unit tests, separate from the Shiny layer.

The app runs on a free hosting tier and may take about 30 seconds to wake up.