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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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Community Forum |
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RWD for Regulatory Decision-Making: Learnings from Use Cases and Demonstration Projects
FDA guidance is clear that real world data (RWD) may be acceptable for regulatory approval when a randomised controlled trial is not feasible and the validity and trustworthiness of the real world study results are clearly demonstrated. To provide more operationalised guidance for meeting these standards, the presenters will share learnings from FDA use cases and ongoing demonstration projects.
This Community Forum will be taking place virtually on 28 January at 14:00-15:00 (GMT) / 9:00-10:00 (EDT) / 15:00 (CET)
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Active since 2014, PHUSE’s Data Transparency Working Group has provided subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate) and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength to strength. These virtual events have created an unrestricted space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions alongside experts in the data-sharing field.
The PHUSE Data Transparency Autumn Event will take place from 4–6 February 2025. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. During this virtual event, presentations will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes.
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We're thrilled to announce a new Working Group event coming your way in 2025 – the PHUSE Real World Data Spring Event!
Taking place 9–10 April, this innovative event will bring the PHUSE Community together to explore the transformative potential of real world data (RWD).
Call for speakers is open, so wherever you are in the world, you can join us virtually – and for free – to share insights, learn and collaborate with like-minded individuals. Find out more about the event here. Look out for registration opening on 17 February!
Here’s your chance to take the virtual stage and share your expertise! We’re looking for speakers to inspire, inform and lead the conversation on RWD. To guide your submission, here are some focus areas that will be central to the event:
- Data sources, lineage and provenance
- Vendor-sponsor governance and alignment
- Representing patient diversity
- Overcoming challenges with unstructured data
Do you have a unique perspective that doesn’t fit into these categories? We encourage you to think outside the box and propose ideas that reflect the cutting edge of RWD.
Submit your 150-word abstract by 22 January.
Status colour Blue title Submit Your Abstract
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We have just published the last Working Group Report for 2024! You can view the Quarter 4 summary here, including the project reports and some of the highlights across our Working Groups for this final quarter. Don’t forget to check out the Working Group Events Report too, which provides a breakdown of the data collected from the Working Group Events for 2024.
Well done to all our Working Groups who have had a fantastic 2024!
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The "Emerging Trends and Technology" (ET&T) Working Group is changing its name! This Working Group will now be called "Emerging Trends and Innovation" (ET&I). Hear from one of the Working Group's Leads, Mike Hamidi, on why they are making this change:
"The proposed name change from Emerging Trends & Technologies to Emerging Trends & Innovation reflects a broader focus beyond just technological enablement. This shift encompasses not only ongoing developments in areas such as AI/ML, digital health technologies, and healthcare standards but also aims to provide deeper insights into these and other evolving topics. We believe this adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry innovations."
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In its 14th year, the PHUSE/FDA Computational Science Symposium (CSS) will be expanding its global reach! In addition to Silver Spring, Maryland, we will be running a simultaneous event in Utrecht, the Netherlands!
Mark Your Calendars!
The US event will be in Silver Spring, Maryland 19-21 May, and the EU event will be in Utrecht, the Netherlands 20-21 May.
Please visit the PHUSE website for more information.
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The Analyses & Displays for Hepatotoxicity project within the the Safety Analytics Working Group has produced a white paper, ‘Recommendations for Analyses and Displays Associated with Hepatotoxicity with a Focus on Phase 2-4 Clinical Trials and Integrated Submission Documents Stage 1: Initial Assessment and Screening for Potential for Hepatotoxicity'. The purpose of this document is to provide recommendations for displaying, summarising, and analysing measures of hepatotoxicity in tables, figures, and listings (TFLs). The suggested TFLs will have implications for what and how liver-related data should be collected.
Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 20 December
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The SEND Industry Feedback Survey project within the Nonclinical Topics Working Group have published their 2025 SEND survey! This is the 9th year the survey has taken place. The survey will be open from December to 15 January and the data collected will be anonymous. The results will be first available at the PHUSE Computational Science Symposium 2025 and will then be posted to the SEND Industry Feedback Survey site.
Status colour Blue title Submit Here
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The Submitting Real World Data project within the Real World Evidence Working Group, has published a Blog. This Blog post explores possible approaches for submission of real world data to regulatory bodies. Real world data, as defined by the Food and Drug Administration in their guidance, comprises data collected from non-interventional study designs. (1) From project group discussions, ‘claims’ and ‘electronic health records’ comprise most real world data used in providing clinical evidence. Fast Health Interoperability Resources, or FHIR, is a platform used by HL7 for health information exchange. (2) This platform is widely used to exchange healthcare information, as far as claims and EHR data is concerned. As a result, a significant portion of real world data used by the pharma/biotech industry follows HL7-FHIR.
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new FAQ! They have answered a FAQ with SDTM/ADaM IG Nuances, which is about the Use of Different Versions of MedDRA SMQs and CMQs for a Single Study. You can view this question and see the FAQ's this project has answered so far via here.
Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global.
The Estimands in Safety Analytics, a new project within the Safety Analytics Working Group, is now calling for volunteers. The value of well-defined safety estimands is not generally appreciated and has not been communicated well to safety scientists.
- Safety analyses are often ambiguous and, in some cases, carry the risk of being misinterpreted.
- A better understanding and consequently a more consistent application of a robust estimand framework in the analysis of safety data would eliminate this ambiguity and drive clarity on both the specific question an analysis addresses, as well as the answer to that question.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 14 February.
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: 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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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: 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 |
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Volunteer Board and contact the PHUSE Office |
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on workinggroups@phuse.global to express your interest. |
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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. |