| 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. |
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 and register now to guarantee your place at each day.
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.
| 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. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate.
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| 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. |
Latest PHUSE Community Forum
RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards – 12 April
In the most recent PHUSE Community Forum, presenters dived into what follows after using real-world data for regulatory submissions, and look into examples of mapping and data handling in two ways (OMOP to SDTM and source/SDTM to OMOP). They explored the challenges of mapping to and from OMOP, which is a more open standard than SDTM and uses a stricter model with strict implementation guides. Catch up by viewing the recording and posting your comments and questions to the Disqus forum. Just log in with your Disqus, Facebook, Twitter or Google account to get started!
The Quality Tolerance Limits (QTL) project, part of the Risk Based Monitoring Working Group, needs your feedback! Are you an industry expert in data science, clinical operations, and/or risk-based quality management who is aware of, or has been involved in the implementation of QTLs? With the valuable feedback received from the PHUSE Community, the project can explore these questions, analyse and incorporate your insights into the project’s White Paper, expected in Q4 2023. Click here to complete the survey before it closes on 19 May.
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 End-to End Open Source Collaboration Guidance 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 on collaborating on open source projects from the perspective of PHUSE individuals. As this is an emerging space within clinical reporting, this has been published as an online web book to help facilitate revisions. The project has endeavoured to link out to resources whilst providing contextualised examples that are tied to the types of collaborations present in late-stage activities. R packages are referenced as an example OSS project that is a focal point today in clinical reporting, but the principles extend to other libraries in Python, Julia, Javascript, and more. Please submit your feedback to workinggroups@phuse.global by 7 July.
Volunteer
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. |
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 |
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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