Hot Topics

Hot Topics

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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 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

Data Transparency

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)

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New Working Group Lead for Data Transparency

New Working Group Lead for Data Transparency

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.

Working Groups Q2 Reports

Working Groups Q2 Reports

The Working Groups Quarterly reports are now published! These reports provide an overview of each of our projects, highlighting key achievements and ongoing activities. You can view the reports and learn about what our Working Group projects have been up to in Q2 here. Additionally, you can find a breakdown of the events that have taken place here.

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Data Transparency

Data Transparency

The Good Transparency Practices project have published a new White Paper. 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.

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Real World Evidence: Calling For Feedback

Real World Evidence: Calling For Feedback

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.

Data Transparency: Calling For Volunteers

Data Transparency: Calling For Volunteers

The PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance project team within the Data Transparency Working Group is calling for volunteers! This project aims to provide feedback on new guidance to accompany the MHRA’s updated clinical trials regulations and how it is written, ahead of the deadline on 10 September.

On 28 April 2025, the UK Parliament and Northern Ireland Assembly approved the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (available via this link). These new regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004, which currently govern the regulation of clinical trials of investigational medicinal products (CTIMPs) in the UK.

New guidance has been published by the UK’s Health Research Authority (HRA) to accompany the Medicines and Healthcare products Regulatory Agency (MHRA)’s updated clinical trials regulations which come into force on 28 April 2026. The guidance explains important points on what will change in terms of processes, legal requirements, and expectations for anyone involved in setting up or delivering clinical trials.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 19 August.

Real World Evidence: Calling For Volunteers

Real World Evidence: Calling For Volunteers

The Missing Data Imputation in RWD Exploration of Multiple Techniques on Open-Source Data project within the Real World Evidence Working Group is calling for volunteers! 

Fitness of RWD to support/generate RWE requires certain processes to be studied (and the ICH E9 guideline to be considered too). One of the core sections is handling missing data. the goal of this project is to publish a white paper which shall explore multiple models available for missing data imputation. 

Click here to hear from one of the projects leads, Likhita Kolli, GSK, who spoke about the project in the June Webinar Wednesday.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 22 August.

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: 

  • The projects must address significant research issues relevant to Computational Science

  • The project must not attempt to address FDA policy issues

  • There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit.