| 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. |
CSS: This year's PHUSE/FDA CSS from the 19-21 September will take place at the Civic Centre, Silver Spring, MD .
The three days will focus on Working Group activities, a highly successful poster session and several networking events. A regulatory plenary session will take place where we will hear from the FDA and EMA regarding data. In addition to these presentations, there will also be two sessions relating to the Office of New Drugs release of standard tables and figures and standard adverse event groupings and queries! There will be two workshops held over the three days, for more information take a look on the PHUSE website where you can find the full agenda and how to register!
Save the date! 5 October 2022 – The Emerging Trends & Technologies Working Group presents the next Community Forum: Challenges in Real World Data Ingestion and Standardization.
Recently Published Deliverables
The Central Monitoring Capabilities project, under the Risk Based Monitoring Working Group have drafted a White Paper titled: Centralized Monitoring: Exploring the Considerations and Challenges of Implementation. The paper describes common obstacles to implementing centralized monitoring (CM), while providing insight and guidance to address those difficulties to enable CM to be a key component to a successful risk based monitoring approach. It covers topics such as CM implementation models, CM change management, the central monitor role, and the execution of CM activities. The team is respectfully calling for public feedback on the White Paper. Please submit any feedback by 6 September to workinggroups@phuse.global.
The Safety Analytics Working Group, are looking for members to join a project to provide consolidated PHUSE feedback on the standard tables and figures and standard adverse event groupings and queries packages, for more information see here. If you are interested in joining the team please email workinggroup@phuse.global.
For information on the PHUSE Working Groups and their projects, click here.
AE Groupings in Safety (AEGiS) – Project Members
The PHUSE Safety Analytics Working Group is launching a new cross-disciplinary project team: AE Groupings in Safety (AEGiS). As noted in the FDA Clinical Review Template (Section 7.1.2 in Attachment B) and the EU SmPC Guideline and emphasised in the 2017 PHUSE adverse events white paper, adverse event categorisation that is too granular can result in underestimation of an event (e.g. somnolence, drowsiness, sedation and sleepiness probably all refer to the same event). This project team will develop points to consider when deciding whether to use a MedDRA-defined grouping of PTs versus creating a custom grouping and will provide recommendations on process/implementation (maintaining custom groupings, analysis planning, ADaM development, tables and figures). Note this project team will not be creating any custom groupings. Final deliverables may include presentations at scientific conferences, publishing a white paper and/or publishing in a peer-reviewed journal.
If you are interested in participating in this project, please email workinggroups@phuse.global.
| Open Source – Regulatory Acceptance of Open-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 is hosting their fourth Open Forum: Regulatory Acceptance of Open-Source Submissions, they will be addressing the following questions:
Come and be a part of our next virtual Open Forum on 12 July at 15:00(BST) 10:00(EDT). |
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 Working Group, has published two new Blogs! The 'Understanding the Data Quality Issues in Real-World Data Through Real-World Examples', 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 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' blog explores the use of Real-World Evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation. 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 Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials, a new project within the Risk Based Quality ManagementWorking Group, is now calling for volunteers. This project aims to to discuss and focus on a robust strategy/process and best 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. |
Working Groups Report: Includes project updates, recent and upcoming deliverables and |
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, biologic and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
- The projects must address significant research issues relevant to Computational Science
- The project must not attempt to address FDA policy issues
- There must be at least one Project Lead personally involved in planning and carrying out the project
New projects can be submitted anytime during the year, click here to submit.
future plans for each Working Group. | |
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. |