Vaccine Extension Package for ADaM in 'R' Asset Library

Programming vaccine specific Clinical Data Interchange Standards Consortium (CDISC) compliant Analysis Data Model (ADaM) datasets in 'R'. Flat model is followed as per Center for Biologics Evaluation and Research (CBER) guidelines for creating vaccine specific domains. ADaM datasets are a mandatory part of any New Drug or Biologics License Application submitted to the United States Food and Drug Administration (FDA). Analysis derivations are implemented in accordance with the "Analysis Data Model Implementation Guide" (CDISC Analysis Data Model Team (2021), < https://www.cdisc.org/standards/foundational/adam/adamig-v1-3-release-package>). The package is an extension package of the 'admiral' package.

Admiral Extension for Vaccines

Explore all the other packages in the {admiral} ecosystem to learn more about ADaM programming in R.

Vaccine extension package for ADaM in R Asset Library {admiral}

Purpose

To provide a complementary (to {admiral}) toolbox that enables users to develop vaccine specific domains.

Installation

The package is available from CRAN and can be installed by running install.packages("admiralvaccine").

To install the latest development version of the package directly from GitHub use the following code:

if (!requireNamespace("remotes", quietly = TRUE)) {
  install.packages("remotes")
}

remotes::install_github("pharmaverse/admiraldev", ref = "devel") # This is a required dependency of {admiralvaccine}
remotes::install_github("pharmaverse/admiral", ref = "devel") # This is a required dependency of {admiralvaccine}
remotes::install_github("pharmaverse/admiralvaccine", ref = "devel")

Dependencies

The latest version of the package works with the latest versions of the packages stated in DESCRIPTION.

If a previous version of the package should be used, it is recommended to use latest version of the dependencies at the point of time when the previous version of {admiralvaccine} was released.

Scope

• Build a toolbox of re-usable functions and utilities to create vaccine-specific ADaM datasets in R in a modular manner.
• All functions are created based upon the ADaM Implementation Guide and aim to facilitate the programming of ADaM dataset standards.
• Initially the package will focus on creating the reactogenicity and immunogenicity domain following flat model as per Center for Biologics Evaluation and Research (CBER) guidelines.In future we will make enhancements as we get updates on Center for Biologics Evaluation and Research (CBER).

Expectations

{admiralvaccine} is expected to complement {admiral} and provide functions to help with the creation of the efficacy endpoints required for vaccine ADaMs.

References and Documentation

• Please refer to the {admiral} References and Documentation

R Versions

Here’s a summary of our strategy for this package related to R versions:

• R versions for developers and users will follow the same as {admiral} core package.
• For development the devel branch of {admiral} core is used as a dependency. For releasing a new {admiralvaccine} version it must run using the latest released {admiral} core version, i.e., main branch of {admiral} core.

Contact

We use the following for support and communications between user and developer community:

• Slack - for informal discussions, Q&A and building our user community. If you don’t have access, use this link to join the pharmaverse Slack workspace
• GitHub Issues - for direct feedback, enhancement requests or raising bugs

Acknowledgments

Along with the authors and contributors, thanks to the following people for their work on the package: Neetu Sangari, Ben Straub, Stefan Bundfuss, Edoardo Mancini, Ross Farrugia, Abdul Khayat, Ankur Jindal, Andrea Pammolli, Daniele Bottigliengo, Ranya Ben Hsain, Lee Armishaw, Hilde Delanghe, Marleen Nijs, Mandy Peng and Tina Zhai.