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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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We have just wrapped up the last Working Group Report for 2024! You can now view the Quarter 4 summary here, where you can see each of the project reports and some of the highlights across our Working Groups for this final quarter. Don’t forget to check out our Working Group Events Report too, where you will see a breakdown of some of the data collected from our Working Group Events for 2024.
Well done to all our Working Groups who have 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 & Innovations 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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Call for Speakers has closed for the Data Transparency Winter Event 2025!
Taking place virtually 4-6 February, this event presents an incredible opportunity to showcase your ideas, share insight and engage with a vibrant community dedicated to advancing data transparency in the industry.
Abstracts are currently being reviewed and the agenda drafted, watch this space for exciting agenda announcement's coming soon!
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The Analyses & Displays for Hepatotoxicity project within 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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Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global.
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The Best Practices in Data Standards Implementation Governance project within the Optimizing the Use of Data Standards Working Group has published a new white paper.
This white paper presents the results of the survey along with feedback from informal discussions at the PHUSE/FDA Computational Science Symposium (CSS) sessions in 2022 and 2023. The data and observations shared are intended to inform industry and identify further projects for exploration while also encouraging industry collaboration for areas which are found to be the most challenging.
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Data Transparency Autumn Event 2025 – Call for Speakers is Open! | ||
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Call for Speakers is officially open for the Data Transparency Autumn Event 2025! This is a fantastic opportunity for those passionate about data transparency to share their bold ideas, fresh perspectives and real-world experience. The event will take place virtually 16–18 September, meaning you can participate from anywhere in the world! Plus, there’s no need to block out the whole day, as sessions are delivered in short bite-sized chunks from 10:00-12:30 (EDT) / 15:00-17:30 (BST) / 16:00-18:30 (CEST) Submit your 150-word abstract by 12 June for the chance to take part in one of the most focused, forward-looking events in the transparency space.
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Real World Evidence Webinar Series | ||
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Webinar 2: Estimands in Real-World Evidence Studies This webinar will explore the pivotal role of estimands in real-world evidence (RWE) studies, bridging the gap between regulatory guidance and practical implementation. The session will address challenges unique to RWE settings, such as heterogeneous patient populations, complex treatment regimens, and the impact of intercurrent events on study outcomes with a focus on generating RWE that can inform regulatory decision-making. Through practical examples, case studies, and an engaging panel discussion featuring domain experts, this session will highlight best practices for defining estimands that enhance the interpretability and reliability of RWE findings. Participants will leave with a systematic approach to estimand definition, empowered to conduct RWE studies that are robust, actionable, and aligned with evolving regulatory standards. This webinar will be held virtually on 5 June 2025 at 11:00 (EDT) / 16:00 (BST) / 17:00 (CEST)
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Community Forum: AI and SaMD in Healthcare: From Compliance to Patient-Centred Innovation | ||
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Digital health technologies (DHTs), such as wearable accelerometers, are increasingly being adopted in clinical trials, as they enable objective and continuous evaluations of health parameters, functions and behaviours in the participant’s naturalistic environment. The continuous data stream provided by DHTs combined with artificial intelligence/machine learning (AI/ML) tools can lead to the identification of novel digital endpoints (NDEs) and measuring objective outcomes that are meaningful to patients. These NDEs can support clinicians with early diagnosis, prognosis, and personalised treatments of a wide range of diseases. To address the need to develop and validate NDEs before their large-scale deployment in clinical trials and gather evidence supporting their regulatory adoption, at Pfizer we have collected in-clinic and at-home data from hundreds of healthy volunteers across age ranges, spanning paediatrics to geriatrics, and device locations. In the first part of this presentation, considerations about the selection of fit-for-purpose DHTs and the validation of AI-driven algorithms for NDEs of gait and physical activity will be discussed as compared to standard measurements. Since understanding individual perception towards using new technologies is crucial for clinical adoption of NDEs, the evaluation of self-reported measures of usability, acceptability, and level of continued usage will also be addressed. Results suggest high reliability and accuracy of DHT-derived gait and physical activity endpoints, for example by effectively tracking walking at different speeds, while ensuring participants’ comfort in wearing DHTs. Finally, the deployment of the validated AI-driven digital biomarkers in clinical studies will be presented, with particular focus on older individuals at risk of frailty and malnutrition. This Community Forum will be held virtually on 18 June at 11:00 (EDT) / 16:00 (BST) / 17:00 (CEST)
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End-to-End RBQM Webinar: Value-Driven Clinical Data Review, Together | ||
Clinical data review is no longer just a technical checkbox – it’s a strategic, cross-functional effort that can make or break the success of a clinical trial. When teams collaborate across functions, align on risk, and focus on value-driven review, the result is more reliable, coherent and compliant trial data. In this session, we’ll explore how to move beyond traditional data cleaning by embracing a collaborative, risk-based approach. Learn how functional interdependencies – when properly understood and leveraged – can drive smarter, more efficient reviews. We’ll also host a dynamic roundtable featuring voices from big pharma, tech and CROs, who will share real-world insights, challenges, and best practices for building effective, cross-functional data review strategies. Whether you’re in data management, clinical operations, biostatistics, or a supporting function, this session will offer actionable strategies to foster collaboration and value-driven data review processes. This webinar will be held virtually on 26 June at 10:00 (EDT)/ 15:00 (BST) / 16:00 (CEST)
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The Implementation of Estimands (ICH E9 (R1)) using Data Standards project within the Optimizing the Use of Data Standards Working Group, have published a new White Paper and Example Document! This white paper provides recommendations and examples to illustrate the implementation of the estimands framework introduced by the ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials [ICH E9(R1), 2019] using data standards (as part of the clinical data flow). |
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The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published its Business Case. Dataset-JSON is a widely accepted data format that will streamline data exchange between organisations. Moving to Dataset-JSON will prepare us for the current digital world and enable companies to more accurately, completely and efficiently represent their clinical research data, to better serve their patients/customers. Dataset-JSON supports current data standards but also allows for standards to evolve and removes current limitations imposed by xpt format. |
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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. |