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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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Registration for the Open Source Open Forum is open!
The Open Source Technology in Clinical Data Analysis (OSTCDA) project is hosting their third Open Forum: Open Source in Pharma, Regulatory Acceptance and Validation, they will be addressing the following questions:
- How do you establish reproducibility and traceability with open-source solutions, e.g. R package management?
- How do you document your trust in an open-source solution to satisfy a third-party inquiry?
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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) |
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Call for speakers is now open for the Data Transparency Autumn Event. Don't miss out on the opportunity to contribute your expertise, innovations, and research by submitting your 150-word abstract before 14 June.
Need guidance? Explore the curated topics below from PHUSE's Data Transparency Leads to spark inspiration for your standout abstract.
- Data Anonymisation Techniques and Experiences
- Risk Quantification
- Data Sharing Initiatives and Processes
- Registries and Results Reporting
- Synthetic Data
- Data Transparency Regulatory Submissions
- Plain Language Summaries (PLSs) and Plain Language Summaries of Publications (PLSPs)
- EU CTR
Status colour Blue title Submit Here
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The Quality and Reusability of Real World Data project within Real World Evidence, has just published two new Blogs! 'Understanding the Data Quality Issues in Real-World Data Through Real-World Examples', this blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using RWD, and 'Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products' this blog explores the use of real-world evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation.
The Best Data Practices for Rare Disease Patient Foundations and Researchers within the Real World Evidence Working Group, has published a new deliverable in the form of a Poster. The Poster provides an overview of Ensuring Registry Data Relevance and Reliability for Regulatory Use.
The Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group has published video 2 of their series. The 'What Will I Receive and When Will I Receive It?’ The video covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. To view the full series of videos created by this team, visit the PHUSE website.
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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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Real World Data Autumn Event – Call For Speakers | ||
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We’re excited to announce Call for Speakers for the Real World Evidence Working Group’s second multi‑day virtual event is now open! Taking place 30 September – 1 October 2026, from 09:00–11:30 (EDT) / 14:00–16:30 (BST) / 15:00–17:30 (CEST). Submit your abstract by 8 May for the chance to present. Focus your submission on these central themes:
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 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: |
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If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 14 June
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- Identifying critical items
- Risk Based data review approaches
- Risk Based Monitoring approach strategy (tSDV/tSDR)
- Usage of analytical tools and methods for data review & central monitoring, including limitations on (statistical) methodologies
- Identification of thresholds or equivalent on limited patient data
- Targeted medical review
- Strategy to adequately anticipate on highly dynamic dataEstablish links with the other work streams on FIH/small studies focus
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 July
Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global.
The Safety Analytics Working Group are pleased to welcome two new Leads to the team! The new leads are Mac Gordon and Ellis F Unger.
Mac Gordon has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Johnson and Johnson for 15 years and in industry for 20 years and Ellis is a board-certified cardiologist, who retired from the US Food and Drug Administration following a 24-year career, where he served in senior leadership roles in the Office of New Drugs, Center for Drug Evaluation and Research (CDER).
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24 April 2026. |
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If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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Working Group Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
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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, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit. |