...
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. |
|---|
...
End to End RBQM Education – Revolutionising Participant Safety Monitoring with Advanced Solutions | ||
|---|---|---|
The End to End RBQM Education project, within the Risk Based Quality Management Working Group are hosting their second webinar on the topic of Revolutionising Participant Safety Monitoring with Advanced Solutions! This session will delve into Adverse Event (AE) monitoring and participant safety with a panel of industry experts who will be sharing their perspectives on the changing landscape of safety monitoring. This webinar will be taking place virtually on 23 April at 10:00–11:00 (EDT) / 14:00–15:00 (CEST) / 15:00–16:00 (BST)
|
Data Transparency Webinar - Data Literacy: Enhancing Trust and Transparency | ||
|---|---|---|
A key aspect of health literacy, especially in clinical research, is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions. The MRCT Center and PHUSE are collaborating to develop a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar as we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community. Key Topics:
The webinar will take place on 3 April, 9:00 (EDT) / 14:00 (BST) / 15:00 (CEST)
|
Real World Data Spring Event 2025 | ||
|---|---|---|
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(BST) / 9:00-11:30(EDT) / 15:00-17.30(CEST)
|
PHUSE Computational Science Symposium (CSS) 2025 | ||
|---|---|---|
In its 14th year, the /wiki/spaces/WEL/pages/38993921 will be in Utrecht, the Netherlands 20-21 May. At the heart of the 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. The CSS agenda will feature a variety of activities, including expert-led plenary sessions, interactive workshops and dedicated Working Group Breakout Sessions that drive forward existing initiatives and explore new ones. Attendees will also have the chance to attend the Poster Session, providing the opportunity to share knowledge and engage in discussions on various computational science topics. PHUSE is excited to welcome attendees from across pharma, CROs, academia, health authorities, technology vendors and SDOs to come together for this collaborative and forward-thinking experience. Please visit the PHUSE website for more information.
|
...
Data Transparency Autumn Event 2025
...
Active since 2014, PHUSE’s 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 PHUSE Data Transparency Autumn Event will take place on 16-18 September 2025. 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.
...
The Analyses & Displays for Hepatotoxicity project within the Safety Analytics Working Group, have published a new White Paper!
This White Paper provides recommendations for displaying, summarising and analysing measures of hepatotoxicity in tables, figures and listings (TFLs). The suggested TFLs will have implications for what and how liverrelated data should be collected. If the data required to populate these TFLs is not collected, then there may be insufficient information to adequately assess the potential for a drug to cause or contribute to the cause of hepatotoxicity.
A new Data Transparency deliverable is out for public review!
The Rare Disease/Small Population Data Sharing project has produced a new White Paper - “Rare Disease Clinical Data Sharing” and are seeking your feedback. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data such as risk of re-identification and invasion of privacy (balanced against maintaining data utility) and understand if, and how, these barriers apply to controlled access data sharing under specific contextual assumptions. The development of strategies to enable rare disease data to be shared effectively and be reused is needed to advance research and clinical trial design where there is significant unmet need.
...
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 SEND Coding Bootcamp is a new project within the Nonclinical Topics Working Group. Which is currently calling for volunteers. The 4-day SEND Coding Bootcamp aims to help those working with SEND datasets become more productive by teaching basic coding and plotting skills. Over the course of a series of separate hands-on coding sessions, participants will learn the basics of programming and plotting using the R programming language. The course will be oriented around SEND datasets and will include reading, writing, plotting, and manipulating SEND datasets stored in .xptformat. Basic knowledge of the SEND standard is expected. No previous knowledge about programming or the R programming language is needed. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 1 April. The Kick-Off Meeting for this project will be held 4 April 2025 16:00 (BST) / 11:00 (EDT) / 17:00 (CEST). |
...
The Use of Git in Statistical Programming is a new project within the Emerging Trends & Innovation Working Group, is calling for volunteers.
There is interest across the pharmaceutical industry in using Git for statistical programming. Some companies have already incorporated Git, or are attempting to, and there are common challenges being faced. In these cases, the introduction of Git has increased the complexity of a statistical programmer’s tasks, which has led to challenges in uptake and to taking advantage of the benefits Git offers. This is an important challenge to overcome for increasing efficiency of operations. The purpose of this Working Group project is to provide the industry with tools and guidance for addressing and overcoming this common challenge.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 3 April 2025.
The Kick-Off Meeting for this project will be held 4 April 2025 15:00 (BST) / 10:00 (EDT) / 16:00 (CEST).
The Anonymization of Imaging Data project is looking for volunteers to join our ongoing project focusing on anonymization and sharing of images in clinical trials. Our recent literature review has highlighted a gap in existing research, particularly in the context of sharing images and related metadata in parallel to clinical trial data. We will focus on DICOM images and related metadata in oncology. Our project will take our collective knowledge of clinical trial data and images to create guidance that will inform de-identification decisions in the anonymization process for the images. There will be a comprehensive review of DICOM image tags and relevant packages and methods that are used to process them. We aim to develop best practices for processing identifiers and anonymising images in oncology, ensuring both privacy and usability. If you have experience in processing and de-identifying images in clinical trials, particularly with DICOM images in oncology, we want to hear from you. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 25 April. The regular meeting series is currently bi-weekly on Tuesdays 16:00 (BST) / 9:00 (EDT) / 17:00 (CEST). |
|---|
...
The clinical study analysis and reporting QC process has not changed in decades. It is widely agreed that there is significant overhead in using double programming, and that this may need to be revisited to accelerate and optimally use programming resources. This process has not been revisited or analysed within a modern context. The purpose of this Working Group project would be to perform this analysis and report findings.
The QC process has significant impact on the adoption of Git in statistical programming, specifically in the complexity in using Git in a way that does not disrupt the QC process. This will also impact on what is perceived as acceptable level of QC for submissions by the industry, including regulators.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 29 April 2025.
...
Working Group Q4 Reports |
|---|
The Working Groups quarterly report is now live! These reports highlight the fantastic progress across our projects, featuring key achievements and the exciting work still underway. Explore the complete reports to see how each project is driving innovation and impact. Revisit the events from this quarter and explore what’s coming up next. |
Optimizing the Use of Data Standards |
|---|
The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data StandardsWorking Group is pleased to announce that all published FAQ’s are now available on the PHUSE Deliverable website. Click here to view the categories of answered FAQs. |
Real World Evidence |
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). |
...
QC Workflow Optimisation | ||
|---|---|---|
The QC Workflow Optimisation project within the Emerging Trends & Innovation Working Group have published a survey exploring the current state of Quality Control across the industry. This survey aims to capture an industry-wide view of current Quality Control practices, how they may need to evolve, and the potential role of emerging technologies such as AI. Your input will help shape future PHUSE discussions, highlight areas for improvement or standardisation, and guide next steps for the QC Workflow Optimisation project. The survey will remain open from 3 December – 13 January. All responses will be collected anonymously.
|
...
Emerging Trends & Innovation |
|---|
The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group, has published a new White Paper, Cloud Services: A Framework for Adoption in the Regulated Life Sciences Industry. This White Paper provides guidance for adopting cloud services in regulated life sciences. It explains how GxP requirements apply to cloud providers and offers a clear framework for planning and executing exit strategies to ensure data integrity, business continuity and compliance. |
Data Transparency |
|---|
The Participant Data Return team has published a blog on their recent survey findings. Participant data return is the act of granting clinical trial participants access to the data that was collected about them during a clinical trial. In current clinical trial practice, we take measurements, conduct tests, and perform procedures. The results are reviewed by the investigator and stored by the sponsor, but participants rarely see their own results. In spring 2025, PHUSE established the Participant Data Return project, with the aim of highlighting current industry practice and identifying gaps and challenges in implementation to speed industry uptake. As a first action, in summer 2025, we assessed the current state of data return throughout the industry by surveying PHUSE member companies. PHUSE received a total of 14 responses representing 14 companies worldwide. The published blog summarises findings and next steps for this project team. If you are interested in getting involved please email workinggroups@phuse.global. |
Data Transparency |
|---|
The /wiki/spaces/WEL/pages/220168194 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 |
|---|
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. |
...
Real World Evidence |
|---|
Community Forum: The Causal Roadmap,Targeted Learning and TMLE: What Is That All About? 29 January 2026 at 10:00-11:00 (EST) / 15:00-16:00 (GMT) / 16:00-17:00 (CET) |
Nonclinical Advance Event – Save the Date |
|---|
The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026. The Nonclinical Advance Event will explore key themes including New Approach Methodologies For Nonclinical Safety Assessment, Nonclinical Predictive Modelling And Machine Learning & PHUSE Project Contributions And Developments Full agenda and registration details coming soon! |
Real World Data Autumn Event – Save the Date |
|---|
We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026. Stay tuned for more details and registration information coming soon! |
...
The Value of Plain Language Summaries of Trial Results (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET. |
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. |
...
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. |
...
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. |