Content Comparison

We're thrilled to announce a new Working Group event coming your way in 2025 – the PHUSE Real World Data Spring Event!

"It will bring together engaged speakers from the field ranging from data vendor and data registry representatives to pharmaceutical and biotech industry representatives who are sharing their knowledge and ideas around Real World Data utilisation in a fast-moving and challenging environment." 

-Berber Snoeijer, ClinLine – Real World Evidence Working Group Lead

The Real World Data Spring Event will take place on 9–10 April 2025 14:00-16:30(GMT) / 9:00-11:30(EST) / 15:00-17.30(CET)

In its 14th year, the /wiki/spaces/WEL/pages/38993921 will be in Utrecht, the Netherlands 20-21 May.

Please visit the PHUSE website for more information.

If you have groundbreaking research, innovative methodologies or impactful case studies, we've got an exciting opportunity for you!

Poster Presentations provides an opportunity to cover any of the Stream topics in a visual and engaging manner. The Poster Session is an opportune time for networking and asking fellow CSS attendees for feedback on your work. Posters are ideal for presentations that include graphics, source code, statistical or thought-provoking concepts, novel data management or handling techniques, and innovative ways to implement data standards. Posters increase visibility, allow participants to review at their own pace and enable conversation about the topics presented.

The Poster Session is taking place on 20 May and will offer an unparalleled platform to showcase your work, receive valuable feedback and engage in Q&A with attendees.

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published three new FAQs! They have answered two FAQs within Data Submission, the FAQ answered looks at the ‘Upversioning SDTM and ADaM Datasets for Older Studies’ and ‘Annotated CRFs for EDC and eCOA’. They have also answered a FAQ within SDTM/ADaM IG Nuances, that FAQ answered looks at the “ADAE dataset: AESEQ or SRCDOM and SRCSEQ'

You can view these questions and see the FAQ's this project has answered so far here. 

Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. 

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.

The Using OMOP and Other Real World Data Standards to Support Regulatory Submissions, a new project within the Real World Evidence Working Group, is calling for volunteers. 

The project includes developing awareness of data standards specific to real-world data to support regulatory purposes. Common data models (CDMs) and taxonomies that are specific to the most commonly used real-world data sources by industry, member companies and regulatory bodies across the globe will be in scope, such as electronic health record sources, patient-reported outcomes, widely accepted claims data sources, and other commonly used observational data. OMOP and the OHDSI community will be the focus, and will be evaluated against other CDMs and standards (such as PCORnet, Sentinel and CDISC).

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 March.

The Kick-Off Meeting for this project will be held 6 March at 14:00-15:00 (GMT) / 9:00-10:00 (EST).

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 15:00 to 17:30 (BST). 

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.

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)

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 virtually on 16 June at 11:00 (EDT) / 16:00 (BST) / 17:00 (CEST)

Data Transparency Autumn Event 2025

Active since 2014, 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 Data Transparency Autumn Event 2025 will take place on 16-18 September. 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. Registration for this event will open in July.

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.