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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 this quarter via here. Additionally, you can find a breakdown of the events that have taken place here.

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.

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 10th 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

Building a Better MDR, a new project within the Optimizing the Use of Data Standards Working Group, is calling for volunteers! This project aims to define a fit-for-purpose MDR in today’s data landscape. The resultant goal is a white paper that is informed by perspectives across the data lifecycle, focusing on:

• Define the evolving role of MDRs in an environment where traditional standards are in flux and regulatory expectations are increasing.

• Clarify the value of MDRs beyond submission use cases - including study build, eCRF design, and traceable programming.

• Explore governance and interoperability models that strike a balance between flexibility and compliance, particularly for data exchange between tools such as EDCs, TMS, and downstream analytics platforms.

• Address real-world pain points in usage, versioning, handoffs between standards managers and programmers, and bridging gaps between metadata specification and operational execution.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 28 July.

The Kick-Off Meeting for this project will be held on 28 July at 15:00-16:00 (BST) / 10:00-11:00 (EDT).

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.