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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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Data Transparency Autumn Event – Call For Speakers | ||
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The Data Transparency Working Group invites abstract submissions for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST). The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data. Focus your submission on these central themes and submit an abstract by 8 May to contribute to the discussion. Click here for more information.
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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 The RWD Guideline for Programming and Analysis Processes Project 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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Data Transparency – Calling For Feedback |
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The EU CTR Implementation Project within the Data Transparency Working Group has finalise a finalised the White Paper ‘Protecting Commercially Confidential Information (CCI) While Complying with the European Union Clinical Trials Regulation 536/2014’. This White Paper offers clear, practical guidance to help clinical trial sponsors navigate the EU Clinical Trials Regulation while safeguarding commercially confidential information (CCI). Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 6 May 2026. |
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