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Mechanizing Clinical Review Processes with R Shiny for Efficiency and Standardization (303501)

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Keywords: fda, biostatistics, clinical reviews, r, shiny, standardized tools

Several staff at the U.S. Food and Drug Administration (FDA) are developing and using standardized R Shiny review tools. The Shiny library in R has emerged as an innovative technology, and its flexibility and interactivity appeal to statistical programmers. We identified several routine, tedious analyses and visualizations in medical product reviews. We are developing web applications with Shiny to produce standardized tools to streamline the identified tasks. This approach aligns with FDA’s goal of mechanizing several traditional processes to increase efficiency. To promote Shiny across the FDA, we initiated an R Shiny Users Group with members from different disciplines across the Center for Drug Evaluation and Research (CDER). The users group facilitates communication across the large and diverse agency. To encourage the sharing of apps, an R Shiny wiki was created to provide information about internal R Shiny tools and the users group. In this presentation we will describe the process of developing standardized tools to integrate in to current and future workflows and how to communicate information while engaging multiple disciplines within a large organization.