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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. |
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Real World Evidence |
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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. |
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Real World Evidence | ||
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Community Forum: Capturing the Patients Voice Through Lived Experience Across Diaries and Social Media 23 April 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)
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Emerging Trends & Innovation |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & InnovationWorking 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 |
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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. |
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Real World Evidence – Calling For Feedback |
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The Quality and Reusability of Real World Data Project within the Real World Evidence Working Group has produced a White Paper ‘Real-World Data Reliability and Integrity: Ensuring Real-World Data is Fit for Use for Regulatory Submissions’. This White Paper focuses on the usability of real-world data sources for regulatory submission purposes. To assess the fit for use of this data, we need to assess the relevance and the reliability of the data. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 24 April 2026. |
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