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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, please email workinggroups@phuse.global.

Registration for this year's Data Transparency (DT) Summer Event is open! The DT Event will take place 20–22 June and will feature thought provoking presentations from specially selected experts within the data sharing field. Click here and register now to guarantee your place at each day. 

PHUSE are extremely proud to welcome the eighth PHUSE Working Group; Real World Evidence. The importance of this industry area has become increasingly apparent over recent years and the launch of this Working Group honours that. Working Group leads, Berber Snoeijer and David Hood, are looking forward to kicking off with exciting projects on real-world data sources, code and analysis techniques, and submission requirements. 

• Quality and Reusability of Real-world Data
• Real World Evidence Guidance
• Submitting Real-world Data 

To volunteer for one or more projects within the new Real World Evidence Working Group, email workinggroups@phuse.global. 

RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards – 12 April
In the most recent PHUSE Community Forum, presenters dived into what follows after using real-world data for regulatory submissions, and look into examples of mapping and data handling in two ways (OMOP to SDTM and source/SDTM to OMOP). They explored the challenges of mapping to and from OMOP, which is a more open standard than SDTM and uses a stricter model with strict implementation guides. Catch up by viewing the recording and posting your comments and questions to the Disqus forum. Just log in with your Disqus, Facebook, Twitter or Google account to get started! 

The Quality Tolerance Limits (QTL) project, part of the Risk Based Monitoring Working Group, needs your feedback! Are you an industry expert in data science, clinical operations, and/or risk-based quality management who is aware of, or has been involved in the implementation of QTLs? With the valuable feedback received from the PHUSE Community, the project can explore these questions, analyse and incorporate your insights into the project’s White Paper, expected in Q4 2023. Click here to complete the survey before it closes on 19 May.

The Comparing Analysis Method Implementations in Software (CAMIS) project, part of the Data Visualisation & Open Source Technology Working Group, have written a White Paper and are calling for your feedback! Explore this guidance document which identifies key considerations when understanding differences in statistical methodology implementations across programming languages. As the pharmaceutical industry increases their use of open source languages for clinical reporting, there is a vital need for discrepancies between open source languages and legacy software to be identified and documented. To avoid duplication of efforts across the industry, the CAMIS project has created a central GitHub repository to store these differences. This white paper highlights the importance of clear specification of statistical methodology in our documentation and calls for community collaboration to populate the repository with explanations of any known differences. Please submit your feedback to workinggroups@phuse.global by 12 June.

The End-to End Open Source Collaboration Guidance project, part of the Data Visualisation & Open Source Technology Working Group, have written a White Paper and are calling for your feedback! Explore this guidance document on collaborating on open source projects from the perspective of PHUSE individuals. As this is an emerging space within clinical reporting, this has been published as an online web book to help facilitate revisions. The project has endeavoured to link out to resources whilst providing contextualised examples that are tied to the types of collaborations present in late-stage activities. R packages are referenced as an example OSS project that is a focal point today in clinical reporting, but the principles extend to other libraries in Python, Julia, Javascript, and more. Please submit your feedback to workinggroups@phuse.global by 7 July.  

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 to submit. 

Working Groups Report: Includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE.