Standard Analyses & Code Sharing
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Script Discovery & Acquisition: The aim of the FDA/PhUSE repository is to make available a set of scripts/tools/programs for data manipulation, reporting and analyses of medical data. There are currently many such tools already available on the internet, but they are disparate and many are not easy to locate. This project aims to bring as many of these together into our open source Code Repository, making them more accessible to the community of statisticians and programmers across pharma, regulators and academia. Key tasks will be identifying, contracting and negotiating with the current owners of the scripts/tools/programs to bring them into the FDA/PhUSE repository.
Repository Content and Delivery: This Working Group relies on distributed volunteers to review, develop, test quality Standard Scripts for general use. Volunteers should be able to easily find ways to contribute, either by improving our processes or working directly on the development and qualification of Standard Scripts. In 2014, we defined a process and associated roles for qualifying repository code which we have further refined and exercised in 2015.
Repository Governance and Infrastructure: This project will establish the basic structure and management of the repository. In it's first incarnation (2012-2015), Google Code was used for the repository. At the CSS 2015 meeting, the decision was made to move to GitHub hosting (Google decided in early 2015 to shut down their public sharing site). Goals of this project are to define and enforce folder structure and naming conventions. To define and enforce existence of required metadata for each scripts and support other projects in what they'd like to see in the repository.
Communications, Promotion and Education: The success of the Working Group 'Standard Analyses and Code Sharing' relies on the acceptance, input, feedback and further development from/by the user community. The Communications Plan conceptualises efficient ways to communicate working group progress and results, e.g. White Papers and the call for Scripts. It will define target groups, timing, communication channels and the presentation.
Analysis and Display White Papers: This project includes the development of White Papers that provide recommended Tables, Figures and Listings for clinical trials study reports and submission documents. The intent is to begin the process of developing industry standards with respect to analysis and reporting for measurements that are common across clinical trials and across therapeutic areas. Script developers could then create scripts consistent with the recommendations for all to use, improving efficiency and safety signal detection.
Test Dataset Factory: Several CS Projects develop and specify medical research methods, features, or processes, and some even create software components or subsystems for common tasks in drug development. As part of these efforts, a variety of SDTM or ADaM test datasets are required. The typical fallback position of project teams is to use data from the CDISC pilot project and/or anonymised study data that are provided by project team members. The Test Data Factory project aims at providing test data formatted in SDTM and ADaM, that support a more systematic and comprehensive testing of these concepts and scripts.