| 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. |
PHUSE/FDA CSS
The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The second webinar took place on 13 July on the topic of Overall Safety Assessment – Standard Safety Tables and Figures. Click here to view the slides! A list of all upcoming webinars can be found here.
| 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 |
Volunteer Opportunities
The Nonclinical Topics Workings Group’s new project. Nonclinical Protocol Automation is now calling for volunteers. This project plans to determine the feasibility of transforming the BioCelerate Nonclinical Protocol Template into a dynamic Microsoft Word document where filling in the template allows output of all fields for machine readability. Determine the feasibility of expanding the OpenStudyBuilder system for nonclinical study usage. Explore the output and API functionality of this system. Based upon conclusions from the above, work with one or both groups to complete a pilot for creating a few model study designs for demonstration of protocol automation.
Real World Evidence Working Group’s new project Real World Data Guideline/White Paper for Statistical Programmers is now calling for volunteers. The aim of this project is for statistical programmers across pharma to collaborate and provide their input to create an RWE Guideline/White Paper for the industry.
Please contact workinggroups@phuse.global to register your interest in volunteering.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. |
The Julia Initiative for High Performance Computing Project have produced a White Paper providing an overview of Julia's features and benefits for high performance computing, including its fast compilation, dynamic typing, multiple dispatch, and built-in support for parallelism. This paper also discusses current real-world use cases of Julia and potential case studies for high performance computing. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 7 August.
The Centralised Monitoring Capabilities Project has produced a White Paper focusing on the value of CM as it relates to the protection of data integrity and quality. This paper also explores the subsequent considerations and challenges in demonstrating this value and has leveraged the industry survey conducted by the Project – exploring case studies and review of industry literature. The team are calling for feedback on the White Paper, please provide any comments to workinggroups@phuse.global by 28 July.
The Bio-research Monitoring Data Reviewer's Guide project has updated their Data Reviewer’s Guide Template (BDRG). Version 3.0 of the BDRG provides regulatory agency reviewers an orientation to the submitted Bioresearch Monitoring (BIMO) data in a consistent way and usable format. The BDRG Package includes an Introduction and Overview, Template, Completion Guidelines and Examples.
The Comparing Analysis Method Implementations in Software (CAMIS) Project has published their White Paper titled 'Key Considerations When Understanding Differences in Statistical Methodology Implementations Across Programming Languages – An Introduction to the CAMIS Project'. This White Paper aims to empower clinical data scientists to make informed choices on the implementation of statistical analyses when multiple languages yield different results.
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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