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We are pleased to announce that Elena Valkanova will be taking over as the new Real World Evidence Working Group Lead. Elena began her career in clinical research more than 20 years ago, specialising in statistical programming and data analysis across diverse therapeutic areas. Throughout her career, she has contributed to the design, validation and reporting of regulatory deliverables, ensuring accuracy, reproducibility and compliance with global standards such as CDISC. Her early academic research into algorithmic game theory focused on developing randomised and strategy-improvement algorithms for simple stochastic games – a rare class of combinatorial problems that lie in both NP and co-NP and have no known polynomial-time solutions – providing a strong foundation in probabilistic modelling, computational complexity, and optimisation. Elena now leads collaborative initiatives to develop practical frameworks and implementation guidance for privacy-preserving methods, including differential privacy, federated learning and synthetic data generation. Her leadership centres on building cross-disciplinary resources that integrate statistical programming, machine learning (ML), artificial intelligence (AI) and large language models (LLMs) to enable compliant, scalable and scientifically robust use of real-world data (RWD). |
Working Group Q3 Reports |
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The Working Groups quarterly report is now live! This report showcases the incredible progress across our projects, spotlighting key achievements and the exciting work still underway. Dive into the full report to explore how each project is driving impact and innovation. Plus, check out a detailed breakdown of the events that have shaped this quarter’s journey. |
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SEND Industry Feedback Survey | ||
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The SEND Industry Feedback Survey project within Nonclinical Topics Working Group have published their 2026 SEND survey! This is the 10th year the survey has taken place. The survey will be open from November 14 to 02 December January the data collected will be anonymous. The results will be first available at the Nonclinical Advance Event 2026 and will then be posted to the SEND Industry Feedback Survey site.
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Data Transparency |
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The PHUSE Stakeholder Review of ISRCTN Results System Prototype team has completed their system review and documented their feedback. The International Standard Randomised Controlled Trial Number registry (ISRCTN) recently released information for public review and comment regarding the new registry they are working on, and the results system prototype was open for review until the end of September. The PHUSE project team assembled to review the prototype was a diverse group of experts from the PHUSE Data Transparency Working Group. For the purposes of providing feedback, fields were tested but no results submitted. The summary of comments, included in the ISRCTN results system prototype feedback collated from our review at PHUSE can be found in this document. |
Data Transparency |
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The /wiki/spaces/WEL/pages/220168194 within the Data Transparency Working Group has published a new response to a question regarding MHRA Clinical Trials Regulation Guidance. On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (available via this link). These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004, which currently govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK. New guidance has been published by the UK’s Health Research Authority (HRA) to accompany the Medicines and Healthcare products Regulatory Agency (MHRA)’s updated clinical trials regulations, which come into force on 28 April 2026. The guidance explains important points on what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials. External stakeholders who wished to share feedback on the newly published guidance were asked to provide their submissions to the HRA by 10 September 2025. View the team's response to the updated guidance here and the associated MHRA algorithm document here. |
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Working Group Q3 Reports
The Working Groups quarterly report is now live! This report showcases the incredible progress across our projects, spotlighting key achievements and the exciting work still underway. Dive into the full report to explore how each project is driving impact and innovation.
Plus, check out a detailed breakdown of the events that have shaped this quarter’s journey. |
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Nonclinical Advance Event – Save the Date |
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming February 2026. More details coming soon! |
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