Standard Analyses & Code Sharing

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Working Group Overview

Name/Vision/Goals Presentation
  • Standard Analyses and Code Sharing (formerly Development of Standard Scripts for Analysis and Programming)
  • Leverage crowd-sourcing to improve the content and implementation of analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.
  1. Establish and maintain a publicly available repository for storing program code to be used as analytical tools for medical research.
  2. Where gaps exist, develop recommendations for analyses and displays in areas that could benefit from crowd-sourcing.
  3. Where gaps exist, develop code for recommended analyses and displays that could benefit from crowd-sourcing (to reside in the repository).

Leadership Team

Name Role Organization E-mail
Mary Nilsson Industry Co-lead and Steering Committee Liaison Lilly nilsson_mary_e (at)
Hanming Tu Industry Co-lead and Steering Committee Liaison Frontage htu (at)
Wendy Dobson PHUSE Project Manager PHUSE

Current Projects

Project Scope Recruiting
Analysis and Display White papers (Mary Nilsson) This project includes the development of white papers that provide recommended Tables, Figures, and Listings for clinical trial 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. Yes
Code Sharing (Repository) (Hanming Tu, Bob Friedman, Gustav Bernard) Establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research and leading to better data interpretations and increased efficiency in the clinical drug development and review processes. Yes
Communication, Promotion and Education (Jared Slain and Wendy Dobson) The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes 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. Yes
Best Practices for Quality Control and Validation (Maria Dalton and Jane Marrer) Quality and accuracy is essential in the health and life sciences industries. Patients and regulators must be able to trust analyses of clinical data. This paper will provide an in-depth review of best practices for robust quality control. The scope of the paper will be quality control of analysis programming of clinical data in health and life sciences organisations. It is applicable to the organisations who produce analyses of clinical data, including Contract Research Organisations. The paper will not discuss oversight of outsourced programming Yes
GPP in Macro Development (Ninan Luke) Macros provide an effective way to automate and reuse code in a standard and consistent manner across SAS programs. This ability to reuse code means that the use of GPP is particularly important in macro code and we think that there is a need to develop a consensus and document good programming prairies specifically for macro programming. Yes
Test Data Factory (Peter Schaefer) 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 anonymized 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. Yes
Key Links Previously published deliverables & News FYI

Small tasks that Working Group members can help with

  • CPE project - Help with entering conferences and due dates for abstract submissions
  • CPE project - After a presentation is given, add the ppt and pdf versions to the wiki

Working Group Meeting Minutes

Starting in 2019, meeting minutes are kept in Teamwork instead of the Wiki which is accessible to Project Members only

Previous minutes can be found here

Conference Records

PhUSE CSS Conferences

Closed Projects

  • P04: Legal ownership and issues in open source repository (Sally Cassells)
    • Task completed, creating a summary is planned
  • P05: Create templates and metadata for documenting scripts and coding practices (Jean-Marc Ferran and Eric Sun)
    • Closed, remaining tasks are folded into RGI project.
  • P06: Refine process for creating and editing scripts in Google Code (Kevin Kane)
    • Closed, any remaining tasks moved to Project 03

Legacy Projects/Information

Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.

FDA Disclaimer

FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.

Disclaimer for Others

Documents and comments provided as part of the PHUSE CSS Working Group efforts represent the individual's best judgment. They do not necessarily reflect the view and/or policies of their company or institution, the employers of the individuals involved or any of their staff.

Note: Individuals participating in PHUSE CSS Working Group discussions on the wiki are responsible for determining whether this disclaimer is sufficient for complying with any relevant procedures from their company or institution.