| 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. |
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 second webinar will be on Overall Safety Assessment – Standard Safety Tables and Figures, taking place on 13 July 15:00-16:30 (BST) / 10:00–11:00 (EDT) . Click here to register!
The Real World Evidence Working Group hosted a Community Forum on Designing your RWD Study: Is Your Data Fit For Purpose?, Rest assured if you couldn't attend, the recording is available to view now!
| 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. |
| 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 Standards Working Group 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 | |
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The Data Visualisation & Open Source Technology Working Group has a 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 |
Volunteer Opportunities
Nonclinical Topics’ 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.
Please contact workinggroups@phuse.global to register your interest in volunteering.
Call for Working Group Leads
All applications are to be submitted to our Working Groups Director, Chris Price, at chris.price@phuse.global. Closing date for applications is 21 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. |
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.
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 |
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. |
| 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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