| 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. |
Registration and Call for Posters for the PHUSE/FDA CSS 2024 is now open!
Come and be a part of the PHUSE/FDA Computational Science Symposium 2024 (CSS) taking place 3–5 June in Silver Spring, MD. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate. Sponsored by Entimo, the Poster Session will take place on Tuesday 4 June. Seize this opportunity and submit a 150-word abstract by 8 March.
Be sure to register by 15 March to use the PHUSE Early Bird discount!
| 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 |
The Risk Based Monitoring Working Group has changed to Risk Based Quality Management. With a wider remit focused on RBQM, this Working Group will identify innovative approaches in the planning (Quality by Design, Critical to Quality, Risk Identification and Characterisation), conduct (Risk Control), and continuous improvement (Risk Review, Risk Communication) elements of RBQM that support proactive management data reliability and participant well-being. The leads have produced a survey so you can have your say in the evolution of this Working Group! Please complete this survey by the 6 March.
The Quality Tolerance Limits project within Risk Based Quality Management Working Group has produced a White Paper 'Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry'. By surveying the industry to gather information on the current use of QTLs, this white paper aims to provide the reader with valuable insights as to the depth and breadth of their use. It will also address how QTLs are utilised in the wider scope of implementing RBQM, and the direction of stakeholders given that the regulations regarding the conduct of clinical trials continue to evolve.Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 8 March.
Volunteer Opportunities
The Risk Based Quality Management Working Group have just initiated a new Project called 'OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM' which is calling for volunteers! They will form an Open-Source TBQM Working Group and an associated development sub-team. If you are interested in joining, please contact workinggroups@phuse.global by 6 March.
The Optimizing the Use of Data StandardsWorking Group is looking for a new Working Group Lead to join their team. Over the last decade the development and adoption of data standards has shown significant promise in improving efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards.The goal of this Working Group is to work together to identify and close those particular gaps that impede industry and the FDA from making the most efficient use of data standards. Click here to see a list of current projects within this Working Group.
Learn more about the roles and the responsibilities of a Working Group Lead and apply by emailing workinggroups@phuse.global. Closing date: 29 March.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 SDTM ADaM Implementation FAQ project within Optimizing the Use of Data Standards are wanting to answer more of your SDTM ADaM questions! There are many questions related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, NMPA). The project's team currently:
1. Collect frequently asked questions (FAQs) from Industry.
2. Assess the appropriateness of a question, develop and review a response, collaborate with CDISC/FDA for clarity if required.
3. Publish the FAQ and responses on the Advance Hub database for helpful implementation/strategy information.
If you have any questions for the team, please contact: workinggroups@phuse.global. You can find the previous questions that have been answered the project page, under Objectives & Deliverables.
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 |
PHUSE Communications
Working Groups Report: Includes project updates, recent and upcoming deliverables and the 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.
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