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. |
Open Source – Regulatory Acceptance of Open Source in Pharma, Regulatory Acceptance and Validation-Source Submissions |
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Registration for the Open Source Open Forum is open! The Open Source Technology in Clinical Data Analysis (OSTCDA) project project is hosting their third fourthOpen Forum: Regulatory Acceptance of Open Source in Pharma, Regulatory Acceptance and Validation-Source Submissions, they will be addressing the following questions:
Come and be a part of the our next virtual Open Forum on 14 June 12 July at 15:00(BST) 10:00(EDT). |
Call for speakers is now open for the Data Transparency Autumn Event. Don't miss out on the opportunity to contribute your expertise, innovations, and research by submitting your 150-word abstract before 14 June.
Need guidance? Explore the curated topics below from PHUSE's Data Transparency Leads to spark inspiration for your standout abstract.
- Data Anonymisation Techniques and Experiences
- Risk Quantification
- Data Sharing Initiatives and Processes
- Registries and Results Reporting
- Synthetic Data
- Data Transparency Regulatory Submissions
- Plain Language Summaries (PLSs) and Plain Language Summaries of Publications (PLSPs)
- EU CTR
The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published a new white paper. A pilot was executed to test the feasibility of using Dataset-JSON as a transport format for study data submitted with regulatory applications. The goal was to demonstrate that Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. CDISC Dataset-JSON is a modern dataset format designed for data exchange. Many software applications already import and export JSON and in the longer term more significant benefits will emerge as the constraints imposed by XPT are removed. Overall, the findings were consistent across industry and the FDA supporting the use of Dataset-JSON as an alternative transport format for XPT v5. There were several key findings from the pilot and the solutions to these will be implemented in Dataset-JSON v1.1 (due end of 2024). PHUSE and CDISC will continue to collaborate with the FDA/PMDA to discuss next steps for regulatory support. FDA/CDER/CBER testing strongly suggests that analytical tools used for regulatory review are updated to take advantage of the metadata and flexibility provided by the Dataset-JSON format. The SEND Industry Feedback Surveyproject within the Nonclinical Topics Working Group, has published the 2024 SEND Survey Results. The survey was presented at the PHUSE/FDA Computational Science Symposium (CSS) 2024 and covered topics such as Manual Edits, Implementing SEND, Harmonisation and Next Steps. The Adverse Event Collection Recommendations project within the Safety Analytics Working Group, has published a new white paper The Adverse Event Collection Recommendations. This white paper provides recommendations for adverse event (AE) collection and associated instructions for Phase II to III clinical trials, building on standardisation efforts by Clinical Data Interchange Standards Consortium (CDISC) and PHUSE. The primary intent is to reduce the variation in AE collection and instructions to improve the site experience and the quality of the data. The Quality and Reusability of Real World Data project within the Real World Evidence, has just Working Group, has published two new Blogs! The 'Understanding the Data Quality Issues in Real-World World Data Through Real-World Examples',this blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using RWD, and Real-World Data (RWD).The 'Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products' this blog explores the use of real-world evidence Real-World Evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation.The Best Data Practices for Rare Disease Patient Foundations and Researchers within the Real World Evidence Working Group, has published a new deliverable in the form of a Poster. The Poster provides an overview of Ensuring Registry Data Relevance and Reliability for Regulatory Use. The Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group has published video 2 of their series. The 'What Will I Receive and When Will I Receive It?’ The video covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. To view the full series of videos created by this team, visit the PHUSE website. |
The Treatment Emergent Definitions Recommendations project within Safety Analytics Working Group has produced a White Paper 'Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials
Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 7 June
TheEstimands for RWD/RWE, a new project within Real World Evidence Working Group is now calling for volunteers. The focus of this project is on best practices of RWD Estimands, not on their implementation using data standards. The team formed will have representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team, which has a White Paper nearing publication and the Estimands Implementation Working Group (EIWG) sub team on HTA and RWE. Both with Estimands expertise, along with representation from teams under the RWE Working Group. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 14 June
The Enhanced Risk-based Quality Management (RBQM) approaches Approaches for First-in-Human and/or small clinical trialsSmall Clinical Trials, a new project within the Risk Based Quality Management Working Working Group, is now calling for volunteers. This project aims to to discuss and focus on a robust strategy/process and best practises practices for:
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 July Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global. |
The Safety Analytics Working Group are pleased to welcome two new Leads to the team! The new leads are Mac Gordon and Ellis F Unger.
Mac Gordon has a master’s in statistics and graduate certificates in public health, pharmacovigilance and pharmacoepidemiology and has been with Johnson and Johnson for 15 years and in industry for 20 years and Ellis is a board-certified cardiologist, who retired from the US Food and Drug Administration following a 24-year career, where he served in senior leadership roles in the Office of New Drugs, Center for Drug Evaluation and Research (CDER).
They will be joining the current Leads Mary Nilsson, Greg Ball and Scott Proestel, you can learn more about the new leads via theSafety Analytics page.TheOptimizing the Use of Data StandardsWorking Group are pleased to welcome two New Leads to the team! The new leads are Sandra VanPelt Nguyen and Edwin van Stein.They will be joining the Current Leads Jane Owens and Janet Low, you can learn more about the new leads via the Optimizing the Use of Data Standards page.Working Groups 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. |