Working Groups Events Report – Q2 2025
Working Group Events |
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This quarter welcomed a new multi-day virtual event and the annual PHUSE CSS in a new location! The inaugural Real World Data Spring Event exceeded all expectations, bringing together 291 attendees from 25 countries and 118 companies to explore the evolving role of real-world data in clinical research. The event was created to harness and promote the developments that we’ve seen in PHUSE Working Group projects, Community Forums and CSS breakout sessions. To allow as much participation as possible, the virtual event was spread over two days, with afternoon talks on 9 and 10 April from 14:00 to 16:30 (BST). Day 1’s presentations focused on use cases of real-world data, covering topics such as AI’s impact on healthcare statistics. Day 2 was centred around standardisation, compliance and data reliability in the space. All recordings and presentation slides are available on the PHUSE Advance Hub.
PHUSE Computational Science Symposium (CSS) In its 14th year, held 20–21 May in Utrecht, the Netherlands, the PHUSE Computational Science Symposium (CSS) 2025 brought together a vibrant community of passionate individuals for a collaborative and engaging event. At the heart of this event is the PHUSE Working Groups’ mission to tackle unmet computational science needs in support of health product development and regulatory review, ultimately bringing safe and effective medical products to those who need them. With two regulatory Plenary Sessions, 21 poster presentations and 29 Breakout Sessions driving Working Group momentum, the CSS delivered connection, clarity and plenty to take forward. For the full details of the event, read our Summary Blog. |
Community Forum |
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Emerging Trends & Innovation AI and SaMD in Healthcare: From Compliance to Patient-Centred Innovation Digital health technologies (DHTs) – such as wearable accelerometers – have been increasingly adopted in clinical trials, as they enable objective, continuous monitoring of health parameters, functions and behaviours in participants’ natural environments. The continuous data streams generated by DHTs, when combined with artificial intelligence and machine learning (AI/ML) tools, led to identifying novel digital endpoints (NDEs) and measuring objective outcomes that were meaningful to patients. These NDEs supported clinicians in early diagnosis, prognosis, and the development of personalised treatments across a wide range of diseases. This Community Forum took place virtually on 18 June 2025. |
Webinars |
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Real World Evidence An Introduction to the Estimands and Target Trial Emulation (TTE) Frameworks This introductory webinar aimed to orient attendees on the intersection of the estimands and target trial emulation (TTE) frameworks, along with a suggested causal roadmap overview. After two presentations from publication authors, there was a panel discussion comprised of a regulatory agency representative and the two authors/presenters. Attendees were expected to have a basic knowledge of estimands from the ICH E9(R1) Addendum. This webinar took place virtually on 22 April 2025. Real World Evidence Webinar Series - Webinar 2: Estimands in Real-World Evidence Studies This webinar explored the pivotal role of estimands in real-world evidence (RWE) studies, bridging the gap between regulatory guidance and practical implementation. The session addressed 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 informed regulatory decision-making. Through practical examples, case studies, and an engaging panel discussion featuring domain experts, the session highlighted best practices for defining estimands that enhanced the interpretability and reliability of RWE findings. This webinar took place virtually on 5 June 2025. Risk Based Quality Management Revolutionising Participant Safety Monitoring with Advanced Solutions Adverse event (AE) monitoring and participant safety are entering a new era. In this groundbreaking webinar, we unveiled how cutting-edge technologies are transforming safety monitoring – enhancing detection, accelerating response times, and setting new standards for excellence. We explored the innovations driving this revolution, unlocking unprecedented opportunities to safeguard participants and optimise trial performance. This webinar took place on 23 April 2025. Value-Driven Clinical Data Review, Together Clinical data review was no longer just a technical checkbox – it had become a strategic, cross-functional effort that could make or break the success of a clinical trial. When teams collaborated across functions, aligned on risk, and focused on value-driven review, the result was more reliable, coherent, and compliant trial data. In this session, we explored how to move beyond traditional data cleaning by embracing a collaborative, risk-based approach. Participants learned how functional interdependencies – when properly understood and leveraged – drove smarter, more efficient reviews. This webinar took place virtually on 26 June 2025. |