| Working Groups Hot Topics |
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 2024 |
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Registration for the |
PHUSE/FDA CSS |
2024 is open! Come and be a part of the PHUSE/FDA Computational Science Symposium |
2024 (CSS) taking place 3–5 June in Silver Spring, MD. |
The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The fourth webinar will take place 4 October on the topic of 'Interactive Safety Graphics for Regulatory Decision-Making'. Click here to register, a list of all upcoming webinars and previous webinars can be found here.
Real World Evidence Community Forum: Experiences with Adapting RWD to CDISC Submission Standards
The Real World Evidence Working Group will be hosting another Community Forum, 5 October 14:00–15:00 (BST) 09:00–10:00 (EDT). Presentations will be on the topic of 'Experiences with Adapting RWD to CDISC Submission Standards'. During this Community Forum, presenters will share their experiences and the challenges they encountered along with the solutions they came up with when working with RWD and CDISC standards. Register here!
| Calling For Feedback |
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The Good Transparency Practices project within the Data Transparency Working Group, is now calling for feedback! This White Paper aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will aim to ensure anonymised data is compliant with the legal requirements as defined by Regulators, as well as preserves as much data utility as possible. Please send in your comments to workinggroups@phuse.global by 3 May. |
Announcements
| New Deliverables |
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The Best Data Practices for Rare Disease Patient Foundations and Researchers within the Real World Evidence Working Group, has published a new deliverable in the form of a poster. The poster provides an overview of Ensuring Registry Data Relevance and Reliability for Regulatory Use. The PHUSE data standards community, which is comprised of leaders and experts responsible for the governance and implementation of data standards across the biopharmaceutical industry, have authored and new White Paper. The Data Standards White Paper highlights current challenges in data standardisation across the biopharma industry and identify opportunities where we can work together to tackle them. The SDTM ADaM Implementation FAQ within |
Optimizing the Use of Data StandardsWorking Group |
NEW SDTM ADaM Implementation FAQ question has been added to their Data Submission page, have a look to see the new and previous FAQs from the project so far.
The Centralised Monitoring Capabilities project within the Risk Based Monitoring Working Group have just published their White Paper: Centralized Monitoring Value: Can Data Quality be Quantified? In which the emerging field of Centralised Monitoring is defined and its impact examined on data quality, patient safety and clinical trial efficiencies. This White Paper dives into the results of the projects own industry survey and examines the benefits and limitations of Centralised Monitoring.
have published a new FAQ! The question they have answered is 'Naming Convention for Split RS Domain', you can view this question and the teams response viaValidation/Conformance Rules page. You can see all the FAQ this project has answered so far via here. Do you have a SDTM ADaM question? You can send your questions to the team by emailing workinggroups@phuse.global. |
Volunteer Opportunities
Volunteer Opportunities | |
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new project, Demonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) Framework.This project aims to extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied. This project is calling for volunteers, to join contact workinggroups@phuse.global by 26 April. The Safety Analytics Working Group is looking for a new Working Group Lead to join their team. This Working Group is a cross-disciplinary collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes. 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 26 April |
The Safety Analytics Working Group's new project, Interactive Analyses and Displays for Laboratory Data is now are calling for volunteers. This project aims to bring together stakeholders from pharma, academia, and regulatory bodies with diverse backgrounds, such as statisticians, clinicians, medical experts, and programmers. The goal is to collaborate on a deliverable concerning the use of interactive displays in the assessment of laboratory data during phase 2-3 clinical trials. The deliverable will be a specification document providing platform-agnostic recommendations to stakeholders about the features and options that should be considered for interactive displays of laboratory data. This project’s scope will encompass considerations for interactive visualizations used in ongoing safety monitoring, regulatory submissions, and publications.
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.
Data Transparency Working Group's new project Anonymization of Imaging Data is now calling for volunteers. This project plans to complete a literature review on types of imaging files including (X-rays, (f)MRIs, CT scans, etc.), their formats (DICOM, NIfTI, etc.), their positions (limbs, heads, organs, etc.) and all associated metadata. There will also be a discussion on data handling, storage and transfer. Any existing guidance and repositories will be reviewed. We will then focus on use cases that will have the most impact based on interest and complexity.
The Quality tolerance Limits Project, within the Risk Based Monitoring Working Group is currently looking for a new co-Lead. The team are working on developing a white paper which is analysing the results of their recent survey. The project aims to define role of QTLs in QbD, in particular the relationship to CTQs (Critical to Quality Factors), Estimands and continuous quality improvement (CQI), Discuss the use of QTLs in Early Development/small studies, bio equivalence and complex designs Discuss examples of how to define QTLs, different methodologies and different parameters in use across the industry, Discuss difficulties and challenges of implementation of QTLs and Examine role of QTLs as part of the of the lessons learned (RCA) feedback loop.
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. |
PHUSE Communications | |
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. |
| New Project Idea? |
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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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