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Working Groups Hot Topics

PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, email: workinggroups@phuse.global.

DT Summer Event

Data Transparency Summer Event: Registration opens 30 May. 

CSS 2022

CSS: Registration now open! Click here to register before 1 July to benefit from the discounted Early Bird rate.

Call for Posters! Submit an abstract here before 10 June. 

Projects Calling for Members

Email workinggroups@phuse.global to get involved

Test Dataset Factory Members 

Several Working Group projects develop and specify medical research methods, features or processes, and some even create software components or sub-systems 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 Dataset Factory project aims to provide test data formatted in SDTM and ADaM that support a more systematic and comprehensive testing of these concepts and scripts.


End-to-End Open–source Collaboration Guidance Members 

The use of open-source languages continues to increase in clinical reporting. This has helped shift pan-industry collaborations to move beyond the traditional domain of collaboration on statistical packages. Within multiple companies, we are seeing a shift where individuals may, as part of their role, contribute primarily to projects in the open-source setting. Numerous collaborations exist, with several coalescing under an umbrella collaboration called the pharmaverse. However, there remains a lack of understanding within companies around the benefits and risks of open sourcing. 

This project is led by two presenters from the PHUSE CSS 2021 open-source panel and continues on from discussions and points at that event. The primary aim of the project is to provide guidance, collaboration and creation of open-source projects, as well as to link out to more information. If gaps are found, they will be noted for later follow-up and potential follow-on projects. 

Deliverables Calling for Feedback 
If you wish to view the extensive list of all PHUSE published deliverables, click here
SEND Industry Feedback Survey  Sponsored by the PHUSE Nonclinical Working Group, the 2022 survey will solicit your input on topics such as scope of SEND, implementing flexibility in SEND, manual editing and non-CDISC proposals.  Please complete the survey to help evaluate the usability of the current SEND standard and to express your preferences for next steps. Click here to complete the survey, closes 23 May. 
Project Idea?

Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

  • The projects must address significant research issues relevant to Computational Science
  • The project must not attempt to address FDA policy issues
  • There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here for template and submission.

Working Groups Latest Report: Q12022

This Report provides a detailed overview of the projects progress this past quarter.


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