Neuroscience Extension Package for ADaM in 'R' Asset Library

Programming neuroscience specific Clinical Data Standards Interchange Consortium (CDISC) compliant Analysis Data Model (ADaM) datasets in 'R'. 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>). This package extends the 'admiral' package.

admiralneuro

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

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

Purpose

To provide a complementary (to {admiral}) toolbox that enables users to develop neuroscience disease area specifics.

Installation

The package is available from CRAN and can be installed with:

install.packages("admiralneuro")

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

pak::pkg_install("admiralneuro", dependencies = TRUE)

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 in time when the previous version of {admiralneuro} was released.

Scope

• Build a toolbox of re-usable functions and utilities to create neuroscience-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 focuses on the most common efficacy endpoint needs for Amyloid PET and Tau PET, but over time we will look to add extra areas such as: cognitive scores, lab biomarkers and questionnaires.

Expectations

{admiralneuro} is expected to complement {admiral} and provide functions to help with the creation of the efficacy endpoints required for neuroscience 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 main branch of {admiral} core is used as a dependency. For releasing a new {admiralneuro} version it must run using the latest released {admiral} core version.

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