| 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 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 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. |
‘Data Integration & Submission Challenges’ – bring your questions to industry experts from across PHUSE, CDISC and the FDA
It is a struggle for sponsors to establish an integration strategy using standardised data and legacy data at the tabulation and/or analysis level as no specific strategy or requirements exist within the industry or from regulatory agencies. The industry continues to face challenges and hurdles with pooling, levelling, traceability, and compliance checks with regards to integration. There are currently no published industry-defined data standards for the submission of an ISS/ISE. PHUSE has also initiated a new project to develop a template, completion guidelines and example documents for an integrated DRG.
The live event addressed questions from the industry on the challenges around data integration and submission of electronic data to the regulatory agencies.
Click here to watch the webinar on demand and view the presentations.
The Data Transparency Summer Event will run for 2.5 hours each day 15:00–17:30 (BST).
22nd–24th June 2021
PHUSE has established itself as the world’s largest home for data transparency events. If you are passionate about advancing this fast-moving field, then this is the event for you.
Join an innovative, informative and inclusive space where knowledge is shared across all Pharma companies, vendors and software companies. The event looks to meet the ongoing needs of data transparency within the clinical development arena and will showcase thought-provoking presentations from industry leaders.
Attendees will have the opportunity to listen to three live presentations and then participate in a joint panel discussion/Q&A session based on the content from the day.
Registration and Call for Speakers is now open! Click here for more information.
Projects Calling for Participants
The Optimizing the Use of Data Standards Working Group is actively seeking a new Project Co-Lead for the Bio-research Monitoring Data Reviewer’s Guide (BIMO) initiative. This role will be working alongside Julie Maynard. Here you will find an overview of the project scope together with an outline of their deliverables and timelines. This is a NEW project, so now would be a great time to get involved and have a real impact on the outcomes.
Click here for more information on the role and how to apply. Closing date for applications is Friday 9th April
The Emerging Trends & Technologies Working Group is actively seeking new members to work on the FHIR team initiative. Here you will find an overview of the project scope together with an outline of their deliverables. The team are currently reviewing these and adapting their timelines accordingly, so now would be a great time to get involved.
If you're interested in getting involved contact workinggroups@phuse.global.
The Synthetic Data Project will be hosting five 90-min training sessions on a monthly basis until July. Hosted by Replica Analytics, the training sessions will review different techniques and explore different use cases relevant to the Life Sciences industry. During the time leading to July, the project team will elaborate on the first deliverable to focus on following the end of the training period. If you want to sign up to the Data Synthesis project and gain access to the PODR, please contact workinggroups@phuse.global. Registration for the 1st April event is now open.
Project Idea?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 |
Have you attended a PHUSE Webinar Wednesday?
They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.Click here to register and view previous presentations. Our PHUSE events are different in both nature and set-up. PHUSE events started back in 2004 with the inaugural PHUSE conference in Heidelberg. Since then PHUSE has been organising events all over the globe. With that, we strive to meet the needs of our global membership to share, advance and connect. All our events are aimed at different audiences. Click the banner above to see upcoming events
to submit. |