| 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. 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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Projects Calling for Participants
Email workinggroups@phuse.global to get involved
Implementation of Estimands (ICH E9 (R1)) using 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.
End-to-End Open–source Collaboration Guidance– Members
The use of open-source languages continues to increase in clinical reporting. This has helped shift pan-industry collaborations to move beyond the traditional domain of collaboration on statistical packages. Within multiple companies, we are seeing a shift where individuals may, as part of their role, contribute primarily to projects in the open-source setting. Numerous collaborations exist, with several coalescing under an umbrella collaboration called the pharmaverse. However, there remains a lack of understanding within companies around the benefits and risks of open sourcing.
This project is led by two presenters from the PHUSE CSS 2021 open-source panel and continues on from discussions and points at that event. The primary aim of the project is to provide guidance, collaboration and creation of open-source projects, as well as to link out to more information. If gaps are found, they will be noted for later follow-up and potential follow-on projects.
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 1 March.
The Analyses & Displays for Laboratory Data team have been collaborating on a White Paper which provides updated recommendations for tables, figures, and listings (TFLs) used to analyse and display laboratory measurement with a focus on Phase 2-4 clinical trials and integrated summary documents. The White Paper is intended to provide advice to sponsors who are developing the analysis plan for Phase 2-4 clinical trials and integrated summary documents, or other documents in which analysis of laboratory measurements are of interest. Although the focus of this White Paper is on study level Phase 2-4 clinical trials and integrated analysis for regulatory submissions, some of the content may apply to Phase 1 studies, ongoing aggregate safety evaluations, or other types of medical research such as observational studies.
The team are calling for public feedback on the White Paper, please submit feedback to workinggroups@phuse.global by 11 March.
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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They run throughout the year around the last Wednesday of every month and include presentations of hot topics in the industry and PHUSE.Click
to submit. |