| 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. |
Data Transparency Summer Event 2022
Data Transparency Summer Event: Thank you to all of our presenters and attendees for once again ensuring the Data Transparency Summer event was a great success! Couldn't attend? Not a problem! Click here to visit the PHUSE Engagement Hub where you can catch up on all previous online events.
| 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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| Open Forum: Open Source in Pharma and Long-Term Dependability |
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The Open Source Technology in Clinical Data Analytics (OSTCDA) project is hosting an Open Forum on the topic of Open Source in Pharma and Long-Term Dependability with speaker Mike Smith. This forum will be taking place on zoom on 17 May 15:00-16:00 BST / 10:00-11:00 EDT. |
| 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. The Quality Tolerance Limits project within the Risk Based Quality Management Working Group have published a new deliverable. The White Paper is on the topic of Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry. This White Paper aims to provide the reader with valuable insights into the depth and breadth of the use of QTLs and addressing how QTLs are used in a wider scope of implementing RBQM. |
Calling for Feedback |
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| The Treatment Emergent Definitions Recommendations project within Safety Analytics Working Group has produced a White Paper 'Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials'.This document defines treatment-emergent events in Phase 1 to 4 clinical trials and integrated summary documents across therapeutic areas. The recommendations described herein were based on the authors’ collective experiences and a survey conducted by the PHUSE Treatment-Emergent Definition Recommendations project team [2] to solicit input from respondents on various TEAE scenarios for a simple clinical study design. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 7 June |
Volunteer Opportunities | |
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TheEstimands for RWD/RWE a new project within Real World Evidence Working Group is now calling for volunteers. The focus of this project is on best practices of RWD estimands, not on their implementation using data standards. The team formed would have representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team, which has a white paper nearing publication as of 2024Q1, and the Estimands Implementation Working Group (EIWG) sub team on HTA and RWE, both with estimands expertise, along with representation from teams under the RWE Working Group. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 7 June 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. |
| Announcement |
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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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The Role of the Statistician and Statistical Programmer in Real-World Data Analysis: The Real World Evidence project, part of the Emerging Trends and Technologies Working Group, hosted the most recent PHUSE Community Forum which took place 6 July, 15:00 (BST)/ 10:00 (EST). This meeting began with a 30-minute presentation focused on the changes necessary to use real-world data. Its not too late to get involved! Join the discussions over on the online Disqus Forum and chat with like minded individuals on how the changes affects the role of the statistical programmer and the statistician.
Recently Published Deliverables
Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and three Examples.
Recommendations for SEND Dataset QC Best Practices – The SEND Dataset QC Best Practices project within the Nonclinical Topics Working Group have been busy working on a new deliverable which has recently been published. The White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report.
SDTM ADaM Implementation FAQ- The SDTM ADaM Implementation FAQ project, under the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under Validation/Conformance Rules. The question is based on whether an SDTM domain that is in the SDTM IG v3.3 be used for a study that is using the SDTM IG v3.2 to map the study data.
AE Groupings for Safety (AEGiS) – The PHUSE Safety Analytics Working Group is launching a new cross-disciplinary project team: AE Groupings in Safety (AEGiS). As noted in the FDA Clinical Review Template (Section 7.1.2 in Attachment B) and the EU SmPC Guideline and emphasised in the 2017 PHUSE adverse events white paper, adverse event categorisation that is too granular can result in underestimation of an event (e.g. somnolence, drowsiness, sedation and sleepiness probably all refer to the same event). This project team will develop points to consider when deciding whether to use a MedDRA-defined grouping of PTs versus creating a custom grouping and will provide recommendations on process/implementation (maintaining custom groupings, analysis planning, ADaM development, tables and figures). Note this project team will not be creating any custom groupings. Final deliverables may include presentations at scientific conferences, publishing a white paper and/or publishing in a peer-reviewed journal.
If you are interested in participating in this project, please email workinggroups@phuse.global.
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 Latest Report: Q22022
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PHUSE Blogs
PHUSE Diversity & Inclusion Survey
Neurodiversity: Join the ConversationCan Clinical Data processed with R be Used in a Regulatory Submission?
Pharma Statistical Programming Heads Council
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