The standardization of nonclinical study data by the Clinical Data Interchange Standards Consortium (CDISC) via the Standard for Exchange of Nonclinical Data (SEND) has created an opportunity for the collaborative development and use of open source software solutions to analyze and visualize toxicology study data. Shiny is an open source R package that facilitates the development of user-friendly, web-based applications. The Pharmaceutical Users Software Exchange (PhUSE) consortium has provided a platform for stakeholders throughout the pharmaceutical industry to collaboratively build and share tools, e.g. R Shiny applications, to enhance the effectiveness and efficiency of drug development. The modeling of standard repeat-dose toxicology study endpoints, e.g. body weights, clinical signs, clinical pathology, histopathology, toxicokinetics, etc., in SEND has created new opportunities for dynamic, interactive visualization of study data above and beyond the static tables and figures typically included in static study reports. For example, clinical pathology data from nonclinical toxicology studies can be difficult to digest when presented as group means in data tables, due to the large number of potentially correlated analytes collected across treatment groups, sexes, and potentially multiple timepoints. An R Shiny application has been developed to allow end users to comprehensively examine these datasets, using a variety of analytical and visualization methods, with relative ease. The application is publicly hosted on shinyapps.io, and the source code can be found on the PhUSE GitHub website.
Kevin Snyder
FDA
Interactive Visualization of Standardized CDISC-SEND-Formatted Toxicology Study Data Using R Shiny
The standardization of nonclinical study data by the Clinical Data Interchange Standards Consortium (CDISC) via the Standard for Exchange of Nonclinical Data (SEND) has created an opportunity for the collaborative development and use of open source software solutions to analyze and visualize toxicology study data. Shiny is an open source R package that facilitates the development of user-friendly, web-based applications. The Pharmaceutical Users Software Exchange (PhUSE) consortium has provided a platform for stakeholders throughout the pharmaceutical industry to collaboratively build and share tools, e.g. R Shiny applications, to enhance the effectiveness and efficiency of drug development. The modeling of standard repeat-dose toxicology study endpoints, e.g. body weights, clinical signs, clinical pathology, histopathology, toxicokinetics, etc., in SEND has created new opportunities for dynamic, interactive visualization of study data above and beyond the static tables and figures typically included in static study reports. For example, clinical pathology data from nonclinical toxicology studies can be difficult to digest when presented as group means in data tables, due to the large number of potentially correlated analytes collected across treatment groups, sexes, and potentially multiple timepoints. An R Shiny application has been developed to allow end users to comprehensively examine these datasets, using a variety of analytical and visualization methods, with relative ease. The application is publicly hosted on shinyapps.io, and the source code can be found on the PhUSE GitHub website.