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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.

Once again we celebrate another successful PHUSE/FDA CSS! Thank you to all the 200+ attendees who helped to ensure the first in-person CSS since the Covid-19 pandemic, was one to remember.
PHUSE/FDA CSS will return for a 12th year so stay tuned for 2023 dates to be announced soon! For more information on PHUSE Working Groups, please contact workinggroups@phuse.global. 

The Analyses & Displays for Laboratory Data project (Safety Analytics) has recently published a White Paper with recommendations for analyses and displays for laboratory data, with a focus on Phase II to IV clinical trials and integrated submission documents. There have been two previous white papers (2013 and 2015). The latest white paper (August 2022) provides updated recommendations. You can view the White Paper here. 

The SDTM ADaM Implementation FAQ project, part of the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under SDTM/ADaM IG Nuances. The question is based on the handling of transgender patients in clinical trials. 

The Office of New Drugs (OND) in the FDA Center for Drug Evaluation and Research (CDER) will release documents for public review on standard adverse event groupings and queries for evaluation of biologic/new drug applications.

In addition to their breakout sessions at PHUSE/FDA CSS 2022 to discuss initial feedback, the Safety Analytics Working Group are currently looking for members to join their brand new project. This project will provide consolidated PHUSE feedback on the standard tables and figures as well as standard adverse event groupings and queries packages. If you are interested in joining, please contact workinggroup@phuse.global.

Best Data Practices for Rare Disease Patient Foundations and Researchers, part of the Emerging Trends & Technologies Working Group, is looking for members to join their project to create a guidance about best data practices for patient foundations and for researchers in the form of decision trees, graphics, short printable materials or videos. Please contact workinggroup@phuse.global for more information. 

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 Latest Report Q2 2022: The report includes project updates, recent and upcoming deliverables and the future plans for each Working Group.

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