| 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) |
Working Groups Events
PHUSE's fourth Data Transparency Event will take place 8–10 February 2022.Consisting of 2.5 hours each day (15:00–17:30 GMT), there will be live presentations and a joint panel discussion/Q&A session based on content shared in this fast-moving field of clinical development
Visit the Working Groups Events page to view all previous event material on-demand.
Projects Calling for Participants
Email workinggroups@phuse.global to get involved
Implementation of Estimands (ICH E9 (R1)) in Data Standards – Members
All clinical studies will be expected to implement the estimands framework as part of the design and analysis, as health authorities across the globe continue to adopt the addendum to the ICH guideline. The Implementation of Estimands project aims to carry out an impact assessment of the estimands framework and provide recommendations/best practices (where applicable) for implementing the framework in the following areas:
- Data Collect Design/CDASH
- SDTM
- ADaM (including handling of intercurrent events, missing data imputation) ‒ Analysis Displays
- cSDRG and ADRG
The PHUSE Treatment Emergent Definition project team has goals of reducing variation in treatment emergent definitions and better harmonizing industry practice. The group developed a survey to collect input on various treatment emergence scenarios and it will play a key role in meeting their objectives. The survey launched in mid-August and to date the group have had approximately 230 respondents. Unfortunately, only 1 person from a regulatory agency has participated so far. The group invite more input from our regulatory colleagues before the survey closes on the 18 February and would appreciate your help with soliciting for more participants from the FDA.
Data Standards Implementation Governance Survey
The Best Practices in Data Standards Implementation Governance project has put together a survey to gather an insight into how organisations are currently governing data standards, including what level of governance exists, the scope of standards governed, how governance is organised, and what are the particular challenges and pain points organisations are experiencing when implementing and governing the standards. We seek responses from anyone who is involved in data standards governance or is a user of data standards, from any functional role. The data from the survey will be used to make recommendations on best practices for data standards governance implementation and to develop further projects for particular areas which are found to be the most challenging. The closing date for this survey is the 1 March.
The purpose of this is to allow up front communications to the FDA regarding sponsor’s consideration and deviations from the latest BIMO Technical Conformance Guide (TCG) and, in an effort to avoid the Information Requests that are currently issued by the agency to sponsors, to address inconsistencies between sponsor’s interpretation of BIMO TCG, format and content of Bio-research Monitoring Data Reviewers Guide.
The team is respectfully calling for public feedback on the package which includes a BDRG template, completion guideline and examples. Before reviewing these documents, please read through the BDRG introduction and overview. Please submit any feedback to Workinggroups@phuse.global by 15 February using the BDRG review feedback tracker to log your comments.
The Harmonization of SEND Implementation to Enable Historical Control Data Analysis team has drafted a White Paper which looks to propose harmonization for SEND Trial Summary (TS) and Trial Set (TX) parameters that are used to identify the names and locations of Test Facilities, Test Sites, and Test Subject Suppliers.
The team is calling for public feedback on the White Paper. Please submit your feedback to workinggroups@phuse.global by 15 February.
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. |
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 |
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