Potential Timing: *Late July/Early August
Duration: 20 -30 Minutes
This Study Group will present on the use of a web based application for Clinical Trial Simulation for Alzheimer’s Trials, presented by doctoral student candidate Haoyu Wang, as part of his summer student internship at Pfizer. The goal was to develop a model-based web application of a previous R package developed ADSIM (1), that utilized a beta regression (BR) model to describe the longitudinal progression of the 11 item Alzheimer’s disease (AD) assessment scale cognitive subscale (ADAS-cog) in AD patients in both natural history and randomized clinical trial settings, utilizing both individual patient and summary level literature data. The application allows rapid simulation-based estimation of rates of progression as a function of user-selected trial entry criteria, and is deployed on the ISOP R-shiny server, and allows allows easy use by drug development team members, including individuals without expertise in modeling and simulation.
Background Resources for ADSIM Package: Code and Materials: https://bitbucket.org/metrumrg/alzheimers-disease-progression-model-adascog/wiki/Home
ADSIM Training Document: adsim_training_doc.pdf
Application Link: Forthcoming