Hot Topics

The Working Groups quarterly report is now live! These reports highlight the fantastic progress across our projects, featuring key achievements and the exciting work still underway. Explore the complete reports to see how each project is driving innovation and impact.

Revisit the events from this quarter and explore what’s coming up next.

Community Forum: The Causal Roadmap,Targeted Learning and TMLE: What Is That All About?

This webinar will be held virtually on 29 January 2026 at 10:00-11:00 (EST) / 15:00-16:00 (GMT) / 16:00-17:00 (CET)

The Nonclinical Topics Working Group is excited to announce a multi-day virtual event coming 10–12 February 2026 at 09:00–11:30 (EST) / 14:00–16:30 (GMT) / 15:00–17:30 (CET).

We have an exciting agenda of expert presentations, interactive breakout sessions and project updates, spread across three days. The event will focus on four core themes – new approach methodologies (NAMs), nonclinical predictive modelling, machine learning and PHUSE project contributions and developments – and enable attendees to explore each topic in depth with leaders from industry, regulatory agencies and the wider PHUSE Community.

Webinar: Implementing Estimands & Target Trial Emulation (TTE) in Real-World Evidence: Case Studies & Perspectives

24 February 2026 at 11:00-12:00 (EST) / 16:00-17:00 (GMT) / 17:00-18:00 (CET).

The End to End RBQM Education project is hosting a new webinar: Decoding AI in Clinical Trials: Practical Applications, Regulatory Reality, and the Road Ahead.

This webinar offers a practical, reality-check view of how AI and large language models are being applied in clinical trial conduct today. It explores real-world use of AI in RBQM, regulatory and compliance considerations, and what generative AI can (and can’t) deliver. Helping organisations prepare for what’s coming over the next 3–5 years.

This webinar will be held virtually on 26 February 2026 at 10:00-11:00 (EST) / 15:00-16:00 (GMT) / 16:00-17:00 (CET).

We’re looking forward to welcoming you back as the Data Transparency Working Group returns with another multi-day virtual event, taking place 15–17 September 2026.

Stay tuned for more details and registration information coming soon!

We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026.

Stay tuned for more details and registration information coming soon!

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here.  

‘CTCAE Upversioning – When should a sponsor organisation decide to upversion CTCAE, DAIDS, or any other toxicity grading standards? How should sponsors handle pooled analyses with varying grading scales?'

Do you have a (FAQ project based) question? Send your questions to the team by emailing workinggroups@phuse.global. 

The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group has published a new white paper, Capturing Computational Workflows in Clinical Trials with BioCompute which is now open for public review.

This white paper explores how the BioCompute standard is being applied in real-world clinical trials, showcasing practical case studies that demonstrate its role in improving reproducibility, transparency, and regulatory communication across complex computational workflows.

The team welcome feedback on the paper from 23 January – 20 February. Please send responses to workinggroups@phuse.global.

The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials project within the Risk Based Quality Management Working Group have published a new white paper: Industry recommendations for Risk Based Quality Management in First in Human and Small Clinical Trials which is now open for public review.

The purpose of this white paper is to provide guidance on the application of Risk-Based Quality Management (RBQM) in First-in-Human (FIH) and small clinical trials. This document aims to support sponsors in adopting risk-proportionate, efficient quality oversight approaches while maintaining patient safety and data integrity. It is intended for clinical operations, quality, and oversight teams involved in the design, conduct, and monitoring of small clinical trials.

The team welcome feedback on the paper from 9 January – 6 February. Please send responses to workinggroups@phuse.global.

The Anonymization of Imaging Data project within the Data Transparency Working Group have published a new white paper: Imaging Data Anonymization Guideline which is now open for public review.

The purpose of this guideline is to define the minimum anonymization standards for DICOM imaging data shared externally via a secure, governed research environment (SGRE). This document aims to ensure that all shared clinical trial imaging data complies with privacy regulations and ethical standards, thereby protecting the identities of clinical trial participants. It is intended for people involved in data processing, anonymization, and external collaborations, as well as for external researchers who will access these anonymized data.

The team welcome feedback on the paper from 6 January – 3 February. Please send responses to workinggroups@phuse.global.