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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, email: workinggroups@phuse.global.

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. 

Estimands in Oncology Safety Task Force – Participants

The Pharmaceutical Industry Working Group on Estimands in Oncology in collaboration with PHUSE has started a Safety Task Force on estimands in safety, focusing on oncology. The Task Force will formulate recommendations regarding formulation and use of safety estimands in oncology clinical trials as well as identifying applications of estimands principles to help improve general safety reporting. Recommendations will include trial design, data collection, and analysis issues and ways to integrate clinical, statistical, operations, and data management aspects of study design and execution cooperatively. Key task force activities will include a dive into literature on the subject, formulation of recommendations, development of white papers, and preparation of journal manuscripts and conference presentations. 

For more information, please contact Jonathan Siegel at Jonathan.siegel@bayer.com. For information on the Pharmaceutical Industry Working Group on Estimands in Oncology, please visit www.oncoestimand.com or contact Working Group co-chairs, Degtyarev Evgeny at evgeny.degtyarev@novartis.com or Kaspar Rufibach at kaspar.rufibach@roche.com. 

The PHUSE Clinical Integrated Study Data Reviewers Guide project has prepared a final draft version of the iADRG. The guide provides regulatory reviewers with additional context for integrated analysis datasets received as part of a regulatory submission. The iADRG is intended to describe analysis data submitted for integrated data summaries (e.g., ISS, ISE, etc.)

The team is respectfully calling for public feedback on the iADRG which includes a template, completion guidelines and examples. Please submit any feedback by Monday 25 April to workinggroups@phuse.global by using the iADRG feedback tracker to log your comments.  

• iADRG Template 
• iADRG Completion Guidelines 
• iADRG Example 1
• iADRG Example 2 with LDPC