| 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. |
Call for Posters and Registration Now Open!
Registration for this year's Data Transparency (DT) Summer Event is open! The DT Event will take place 20–22 June and will feature thought provoking presentations from specially selected experts within the data sharing field. Click here to register for all three days.
PHUSE are extremely proud to welcome the eighth PHUSE Working Group; Real World Evidence. The importance of this industry area has become increasingly apparent over recent years and the launch of this Working Group honours that. Working Group leads, Berber Snoeijer and David Hood, are looking forward to kicking off with exciting projects on real-world data sources, code and analysis techniques, and submission requirements.
To volunteer for one or more projects within the new Real World Evidence Working Group, email workinggroups@phuse.global.
The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The first webinar will be on Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting and will be held on 15 June (15:00-16:30 BST). Click Here to Register.
The RWE Working Group will be hosting a community forum on Designing your RWD Study: Is Your Data Fit For Purpose? This Community Forum will take place on 6 July , 14:00–15:00(BST)/09:00–10:00 (EST). Please email workinggroups@phuse.global to register!
The Comparing Analysis Method Implementations in Software (CAMIS) project, part of the Data Visualisation & Open Source Technology Working Group, have written a White Paper and are calling for your feedback! Explore this guidance document which identifies key considerations when understanding differences in statistical methodology implementations across programming languages. As the pharmaceutical industry increases their use of open source languages for clinical reporting, there is a vital need for discrepancies between open source languages and legacy software to be identified and documented. To avoid duplication of efforts across the industry, the CAMIS project has created a central GitHub repository to store these differences. This white paper highlights the importance of clear specification of statistical methodology in our documentation and calls for community collaboration to populate the repository with explanations of any known differences. Please submit your feedback to workinggroups@phuse.global by 12 June.
The SEND Industry Feedback Survey project, part of the Nonclinical Topics Working Group, are calling for your feedback on their 2023 survey! The aim of the survey is to expand on the results from last year’s topics and determine the reasons for the majority of respondents making manual edits and what solutions, such as automation, are being used to address them. Results of the survey will be presented at the PHUSE/FDA CSS. Please complete the survey by 19 June.
Patient foundations frequently develop and run patient registries, but deciding on the strategy, such as which data to collect and how to make sure it’s useful and meaningful, can be a challenge. The PHUSE project 'Best Data Practices for Rare Disease Patient Foundations and Researchers' was established to develop best data practices for patient foundations and researchers who work with them, inform industry of the registries run by patient communities, and build bridges between patients and industry, which will result in better data and inclusion of the patient voice into drug development. See all resent deliverables below.
- Myths VS Facts About Patient Registries
- Patient Registry Transparency Checklist For Patient Foundations
- Patient Foundations Guide to Starting a Registry
| 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 previous RWE Working Group released their first White Paper: ‘Basic Considerations for the Use of Real World Evidence in Support of Regulated Clinical Trial Submissions’ in July 2020. Since then, the inclusion of real-world data in regulated clinical trials has gained significant prevalence. During the PHUSE/FDA Computational Science Symposium 2021, it became clear that companies are still insecure about the use of real-world data for regulatory submission trials due to lack of clear guidelines and standards. Since then, the FDA have released a number of draft guidelines on the use of real-world data for public review, which is discussed in this White Paper. It serves as a reference for relevant guidelines and articles related to the use of RWD/RWE for regulatory submissions.
Volunteer
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, clickhere |
, read the Welcome Pack |
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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. |
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 |
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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