DIsproportionality ANAlysis and Pharmacovigilance in the FAERS • DiAna

The goal of DiAna is to enchance the transparency, flexibility,replicability, and tool exchange capabilities within the domain of pharmacovigilance studies. This specialized R package has been meticulously crafted to facilitate the intricate process of disproportionality analysis on the FDA Adverse Event Reporting System (FAERS) data. DiAna empowers researchers and pharmacovigilance professionals with a comprehensive toolkit to conduct rigorous and transparent analyses. By providing customizable functions and clear documentation, the package ensures that each step of the analysis is fully understood and reproducible. Pharmacovigilance studies often require tailored approaches due to the diverse nature of adverse event data. The package offers a range of versatile tools that can be seamlessly adapted to different study designs, data structures, and analytical goals. Researchers can effortlessly modify parameters and methods to suit their specific requirements. Collaboration and knowledge-sharing are fundamental to advancing pharmacovigilance research. DiAna plays a pivotal role in enabling the exchange of tools and methodologies among researchers. Its modular design encourages the development and integration of new analysis techniques, fostering a dynamic environment for innovation. DiAna simplifies the process of importing cleaned FAERS data, retrieving cases of interest, conducting descriptive analysis, and performing disproportionality analysis. Whether you’re a novice or an expert in pharmacovigilance, DiAna is designed to make your analyses easy and efficient.

Prerequisites: Installing R and R Studio

Before you can start using DiAna, you need to have R and R Studio installed on your system. If you haven’t installed them yet, follow these simple steps:

Installing R Visit the official R project website (https://cran.r-project.org) and download the appropriate version of R for your operating system (Windows, macOS, or Linux). Run the installer and follow the instructions to complete the installation. R provides a powerful and flexible environment for statistical computing and graphics, forming the foundation for your data analysis with DiAna.
Installing R Studio R Studio is an integrated development environment (IDE) for R that makes your R programming easier and more efficient. Once R is installed, go to the R Studio website (https://posit.co/download/rstudio-desktop/) and download the free version of R Studio Desktop. Install R Studio by following the installation instructions for your operating system.

With R and R Studio installed, you have a comprehensive and user-friendly environment ready for conducting pharmacovigilance analyses using DiAna.

Setting Up Your DiAna Project

For an organized and efficient workflow, we recommend creating a dedicated project for your DiAna analyses. Follow these steps to set up your DiAna project in R Studio:

Open R Studio: Start by opening R Studio on your computer. If you’ve just installed R Studio, you can find it in your applications or programs menu.
Create a New Project: In R Studio, click on File in the upper left corner, then select New Project. Choose New Directory and then New Project. Name your project (e.g., “DiAna”) and specify a location on your Desktop or any preferred directory.
Install the DiAna package: Begin by installing the DiAna package from GitHub writing and running the following lines in the console:

install.packages("devtools")
devtools::install_github("fusarolimichele/DiAna_package")

It may be useful to run this command from time to time to download the latest update to the package (e.g., bugs solved, new or improved functions)

Setup the DiAna project: The first time we use DiAna, we have to set up the folder where the data will be stored together with the results of the analyses. This command will require a good internet connection. The better your internet connection, the faster the download. It usually takes between a few minutes and 20 minutes. On the console, we run the two rows below (note that rows preceded by a # are comments and not commands):

library(DiAna)
setup_DiAna(quarter = "24Q1")
# input yes when asked to download the FAERS

With library DiAna we have imported the DiAna package (i.e., the toolbox with all the functions that we will use in our analyses). With setup_DiAna(quarter=“24Q1”) we are automaticatilly setting up the project: it will create a folder to store cleaned FAERS data, that will be downloaded from an OSF repository (in particular we are downloading the entire FAERS database, including all the quarters up to the 24Q1). The entire cleaning process is made transparent on the github (https://github.com/fusarolimichele/DiAna). It will also create a folder for external sources and a folder to store projects. In the external sources, it will also download the DiAna dictionary used to translate free text drug names into active ingredients, a linkage to the ATC code, and other useful data sources.

Some external sources are not available for download because they require subscription (e.g., MedDRA).