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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. |
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| Community Forum: Regulatory Landscape of AI/ML in DHTs (Current Landscape, Knowledge Gaps, Best Practices for Regulatory Submissions, Challenges of Regulating AI) |
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The Emerging Trends & Technologies Working Group is hosting its second Community Forum of the year, Regulatory Landscape of AI/ML in DHTs (Current Landscape, Knowledge Gaps, Best Practices for Regulatory Submissions, Challenges of Regulating AI). We will be hearing from both FDA and Pfizer speakers, who will be looking at how Digital Healthcare Technologies (DHTs) show significant potential for enhancing data acquisition in clinical trials by enabling objective and accurate data collection. Examples of DHTs include wearable devices – sensors, smartwatches, fitness trackers – that continuously monitor vital signs, physical activity, sleep patterns, and medication adherence. However, the emergence of DHTs also raises regulatory-related questions. In this PHUSE Community Forum, we will discuss the development of digitally derived measures (clinical outcome assessments and biomarkers) and germane regulatory policies from the perspectives of government and industry experts. This Community Forum will be taking place over Zoom on 25 September at 13:30-14:45 (BST) / 08:30-09:45 (EDT). |
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The Open Source Technology in Clinical Data Analysis (OSTCDA) project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting.
A significant amount of time and energy has been invested in recent years exploring the desirability (do we want it?), feasibility (can we do it?), and viability (is it worth it?) of integrating open source solutions into our clinical data pipelines which transform source data into clinical study reports and submission data packages. In this October edition of the Open Source Open Forums, we will provide an update on the status of this initiative and continue to hear from you on what we’ve missed so far.
When this manuscript is complete, we hope to put to rest some of the burning questions that we believe we now know the answers to. This will allow industry, and all the passionate people in it, to look ahead and start tackling the next horizon of challenges related to using open source solutions for clinical data pipelines. We hope you will contribute your expertise to this effort. The OSTCDA Project will be hosting their next forum to discuss the above, titled Open Source Technologies in Clinical Data Analysis.
This Forum will be taking place over Zoom on 11 October at 15:00-16:00 (BST) / 10:00-11:00 (EDT).
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RWD Sources – How the Genesis of Your Data Determines What Questions You Can Answer.
When considering sources of RWD, it is important to consider more than just the number of available patients. Recently released guidance from the FDA encourages researchers to build accurate, complete and traceable real-world datasets. Combining data from structured and unstructured electronic health record data, closed claims, and other sources is essential to building the patient journey.
In our October Community Forum, we will explore two different angles of RWD sourcing from the provider’s point of view:
- Tim (Verantos) will share with us novel insights into unstructured data and examples of the value that can be leveraged from such data.
- Matt (Azimuth) will share with us details and example analyses of a unique research data source derived from linking claims and EHR data hosted by the Department of Defense network.
Come and join us for what promises to be another very interesting Community Forum!
This Forum will be taking place over Zoom on 24 October at 14:00-15:00 (BST) / 9:00-10:00 (EDT).
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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 took place from 17–19 September 2024. During this virtual event, presentations were delivered across the three days in bitesize chunks. Each day also hosted a panel discussion and Q&A session focused on the day's themes.
Visit the PHUSE archive for all previous event recordings and presentations.
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Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global.
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The Quality and Reusability of Real World Data project within the Real World Evidence Working Group has published its third Blog Post, RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making. This Blog will explore the main messages in the regulatory guidance, what challenges we foresee in applying it, and how registry data can be used in regulatory applications.
You can learn more about this project and read their previous blogs here.
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The CDISC Standard for Exchange of Nonclinical Data (SEND) data standard has created new opportunities for collaborative development of open-source software solutions to facilitate cross-study analyses of toxicology study data.
A sub team of the BioCelerate SEND Implementation for Cross Study Analysis Initiative was formed and through collaborative efforts via a public–private partnership between BioCelerate and the FDA/Center for Drug Evaluation and Research (CDER), they worked to develop and publicise novel methods to facilitate cross-study analysis of SEND datasets.
As part of this work in collaboration with the Pharmaceutical Users Software Exchange (PHUSE), an R package called sendigR has been developed to enable users to construct a relational database from a collection of SEND datasets and then query that database to perform cross-study analyses. The sendigR package also includes an integrated Python package, xptcleaner, which can be used to harmonise the terminology used in SEND datasets by mapping to CDISC controlled terminologies. This package, sendigR, will provide data scientists and toxicologists with a free, open-source tool that can be utilised to query large repositories of electronic standardised toxicology study data. sendigR was published to the Comprehensive R Archive Network (CRAN) and GitHub - phuse-org/sendigR: Enable Cross-Study Analysis of 'CDISC' 'SEND' Datasets. An R Shiny web application was included in the R package to enable toxicologists with no coding experience to perform historical control analyses. Experienced R programmers will be able to integrate the package functions into their own custom scripts/packages and potentially contribute improvements to the functionality of sendigR.
To learn more, read the sendigR accompanying manuscript here: Frontiers | sendigR: an R package to leverage the value of CDSIC SEND datasets for cross-study analysis (frontiersin.org)
sendigR reference manual: Enable Cross-Study Analysis of CDISC SEND Datasets • sendigR (phuse-org.github.io)
sendigR R Shiny demo app: phuse-org.shinyapps.io/sendigR/
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Working Group Q4 Reports |
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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. |
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Real World Evidence |
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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 | ||
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The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026 at 09:00–11:30 (EST) / 14:00–16:30 (GMT) / 15:00–17:30 (CET) We have an exciting agenda of expert presentations, interactive breakout sessions and project updates, spread across three days. The event will focus on four core themes – new approach methodologies (NAMs), nonclinical predictive modelling, machine learning and PHUSE project contributions and developments – and enable attendees to explore each topic in depth with leaders from industry, regulatory agencies and the wider PHUSE Community. Full agenda and registration details coming soon!
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Data Transparency Autumn Event – Save the Date |
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We’re looking forward to welcoming you back as the Data Transparency Working Group returns with another multi-day virtual event, taking place 15–17 September 2026. Stay tuned for more details and registration information coming soon! |
Real World Data Autumn Event – Save the Date |
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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! |
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Imaging Data Anonymization Guideline |
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The Anonymization of Imaging Data project within the Data Transparency Working Group have published a new white paper: Imaging Data Anonymization Guideline which is now open for public review. The purpose of this guideline is to define the minimum anonymization standards for DICOM imaging data shared externally via a secure, governed research environment (SGRE). This document aims to ensure that all shared clinical trial imaging data complies with privacy regulations and ethical standards, thereby protecting the identities of clinical trial participants. It is intended for people involved in data processing, anonymization, and external collaborations, as well as for external researchers who will access these anonymized data. The team welcome feedback on the paper from 6 January – 3 February. Please send responses to workinggroups@phuse.global |
QC Workflow Optimisation | ||
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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.
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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. |
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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. |
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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. |