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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?
Come and be a part of our next virtual Open Forum on 14 June at 15:00(BST) 10:00(EDT).
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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 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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Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 7 June
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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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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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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. |