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. |
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Data Transparency |
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The Data Transparency Autumn Event will take place from 16–18 September 2025. 10:00-12:30 (EDT) / 15:00-17:30 (BST) / 16:00-18.30 (CEST) |
New Working Group Lead for Data Transparency |
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The Data Transparency Working Group welcomes a new lead Abby McDonell! Abby previously co-led the PHUSE Good Transparency Practice Working Group project, where she helped define best practices for data transparency and created guidance to ensure anonymised data complies with legal requirements while preserving data utility. Abby is a Senior Program Manager for the Clinical Trial Transparency team at Privacy Analytics. Abby leads teams that leverage advanced AI-enabled technology to deliver anonymisation services for top 10 pharma customers. |
Data Transparency |
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The Good Transparency Practices project has published a new Guideline. Good Transparency Practice (GTP) is a guideline developed by the PHUSE Data Transparency Working Group to create a set of best practices to govern the anonymisation of clinical trial data, for external sharing or disclosure. Although there are transparency initiatives across the globe, with differing guidelines, the common goal is to uphold patient privacy and data utility to the highest standards. |
Data Transparency |
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The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group has published a new White Paper. The purpose of this White Paper is to review potential barriers to the sharing of rare disease data such as risk of re-identification and invasion of privacy (balanced against maintaining data utility) to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions. |
Real World Evidence: Calling For Feedback |
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The RWD Guideline for Programming and Analysis Processes project within the Real World Evidence Working Group has produced a White Paper, ‘RWD Guideline for Programming and Analysis Processes’ which is calling for feedback. As per FDA1.1, Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples include data derived from Electronic Health Records (EHRs), Claims and/or billing data, Product and/or disease registry data, other data sources that can inform on health status (e.g., data collected from wearables, patient generated data). Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 5 September. |
Risk Based Quality Management: SDR/SDV in China Survey |
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The Risk Based Quality Management Working Group have produced a survey on the topic of SDR/SDV in China. The goal of this survey is to gain insight into how companies across the industry are implementing SDR and SDV in sites in China. The output of the survey will be used to develop a reference document for informing future study approaches and/or adjusting current approaches to better align with global standards. The closing date for completing the survey: 20 September. |
If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. |
Working Group 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. |
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. |