Working Groups Report – Q1 2026
Q1 Summary |
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The PHUSE Working Groups made a strong start to 2026, delivering new thought leadership, launching innovative projects, and expanding opportunities for collaboration across our global community. The first quarter saw three new published deliverables, the launch of a brand-new multi-day virtual event, and the introduction of a new collaborative project, highlighting the continued momentum and impact of Working Group activity. |
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Data Visualisation & Open Source Technology |
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PharmaForest: A Collaborative Repository of SAS Packages for Pharmaceutical Industry project team within the Data Visualisation & Open Source Technology Working Group. PharmaForest is a collaborative initiative focused on improving how SAS programming is developed and shared across the pharmaceutical industry. Built on the SAS Packages Framework (SPF), it promotes reusable, standardised SAS packages to reduce duplication, improve efficiency and support compliance. By combining an open package repository with community collaboration and practical guidance, PharmaForest helps move SAS programming from siloed approaches to a more scalable, industry-wide model. |
Closed Projects |
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Published Deliverables |
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There have been three published deliverables this quarter: Emerging Trends & Innovation The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper titled ‘Capturing Computational Workflows in Clinical Trials with BioCompute’. This white paper explores how the BioCompute framework can transform the way computational workflows are captured and communicated in clinical trials. As bioinformatics analyses become increasingly complex, consistent and transparent documentation is essential for reproducibility and regulatory confidence. Through practical case studies, the paper demonstrates how BioCompute enables structured, auditable workflows across diverse data types, including omics and imaging, while supporting more efficient collaboration and regulatory submissions. Real World Evidence The RWD Guideline for Programming and Analysis Processes project within the Real World Evidence Working Group has published a new white paper. This paper offers practical guidance for statistical programmers on applying real‑world data (RWD) to produce regulatory‑grade real‑world evidence (RWE), covering study design, data fitness, governance, ethics, vendor engagement, bias management, and regulatory submission considerations. Optimizing the Use of Data Standards The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team’s response to the following question here. “CTCAE Upversioning – When should a sponsor organisation decide to upversion CTCAE, DAIDS, or any other toxicity grading standards? How should sponsors handle pooled analyses with varying grading scales?” |
Deliverables Under Review |
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