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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 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 take place be held virtually on 16 18 June at 11:00 (EDT) / 16:00 (BST) / 17:00 (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 Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
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