Very few industry-wide standards exist for clinical reporting, but open-source technologies are bridging this gap. This presentation introduces our R package and Shiny application, Carver (Clinical Analysis Report and Visualization Ensemble in R), which generates clinical submission-ready tables and graphs.
An earlier version focusing on Adverse Events related reports was developed by our team in collaboration with Phuse, ASA and FDA. It is now expanded as an open-source Pfizer project, under spotlight of CDISC Open Source Alliance (COSA). This project references FDA Integrated TLF Guide, CDISC Guidelines and CDISC Standard Data.
{carver} uses standardized functions to build multiple clinical reports – under domains like Adverse Events, Lab Findings and Demography in Therapeutic Areas like Vaccine and Oncology. In addition to templates to create static tables and figures, the modularized Shiny application can also be used to generate interactive plots – with a feature to drill down to patient-level analysis. {carver} uses packages from the tidyverse suite, plotly, ggsurvfit, shiny, shinydashboard, shinyBS etc. For tables, we built a wrapper around Flextable package to dynamically fit a submission-ready format. The R functions are unit-tested, use tidy principles and CI/CD workflows were implemented.
We aim for {carver} to be used for regulatory submissions and for clinical review. Another potential outcome could be to embed study data within a Shiny Dashboard and include it in clinical submission-package. We are seeking collaborators to expand its reporting capabilities across the pharma industry.
Aravind Reddy | Smriti Anand
Pfizer | Pfizer
Clinical Analysis Report and Visualization Ensemble in R (carver)
Very few industry-wide standards exist for clinical reporting, but open-source technologies are bridging this gap. This presentation introduces our R package and Shiny application, Carver (Clinical Analysis Report and Visualization Ensemble in R), which generates clinical submission-ready tables and graphs. An earlier version focusing on Adverse Events related reports was developed by our team in collaboration with Phuse, ASA and FDA. It is now expanded as an open-source Pfizer project, under spotlight of CDISC Open Source Alliance (COSA). This project references FDA Integrated TLF Guide, CDISC Guidelines and CDISC Standard Data.  carver  uses standardized functions to build multiple clinical reports – under domains like Adverse Events, Lab Findings and Demography in Therapeutic Areas like Vaccine and Oncology. In addition to templates to create static tables and figures, the modularized Shiny application can also be used to generate interactive plots – with a feature to drill down to patient-level analysis.  carver  uses packages from the tidyverse suite, plotly, ggsurvfit, shiny, shinydashboard, shinyBS etc. For tables, we built a wrapper around Flextable package to dynamically fit a submission-ready format. The R functions are unit-tested, use tidy principles and CI/CD workflows were implemented. We aim for  carver  to be used for regulatory submissions and for clinical review. Another potential outcome could be to embed study data within a Shiny Dashboard and include it in clinical submission-package. We are seeking collaborators to expand its reporting capabilities across the pharma industry.