Working Groups

More than 30 participants from pharmaceuticals, CROs, software and academia, as well as CDISC and data privacy experts, have collaborated on developing a data de-identification standard for SDTM (known as the “PHUSE de-identification standard”). Since then the project has expanded to address EMA Policy 0070 matters, create a Data Transparency Roadmap across jurisdictions and, recently, to address aspects of GDPR that are relevant for the conduct of clinical trials.

The Data Transparency Working Group also reviews on a regular basis draft deliverables or guidance from regulatory bodies (e.g. the EMA, Health Canada), other industry organisations (e.g. TransCelerate) and academia (e.g. Cochrane).

Leads: Stephen Bamford, Jean-Marc Ferran, Muhammad Oneeb Rehman Mian & Devaki Thavarajah

Data Visualisation & Open Source Technology aims to support, address and answer pertinent questions around data visualisation and open-source technology. The combination of these two subjects is natural in today’s environment given the powerful data visualisation tools within the open-source languages available today. Some of the questions, amongst others, that we intend to address are:

• How do you safely use open-source languages for analytics and submissions within a regulatory environment?
• What are the potential uses of open-source software within a company outside of data analysis for a submission?
• How can interactive visualisations be leveraged appropriately within a clinical environment?
• What are the best practices for creating powerful interactive visualisations?

Leads: Nicolas Masel, Mike Stackhouse & Hanming Tu

Initiated in 2013, this Working Group aims to provide an open, transparent forum for cooperatively sharing and investigating how new technologies, tools and approaches can support clinical data science. The projects are selected with the aim of assessing, understanding, describing, instructing and offering guidance about how new technologies can be used in the development of new medicines.

The projects range in scope from investigations into new technological innovations and how they can be used, through to guidance and training for new and developing standards, as well as metrics and benchmarking initiatives to support successful operational implementation.

Leads: Mike Hamidi & Stuart Malcolm

Our focus is on using informatic approaches and standards for delivering ideas and solutions to nonclinical data challenges. The Nonclinical Topics Working Group aims to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and to establish an innovative framework for addressing them in a collaborative manner through limited-term projects.

Leads: Sue DeHaven, Michael DeNieu & Kevin Snyder

Over the last decade there has been a significant development and adoption of data standards, showing a promising improvement in the delivery of data to support drug product and device submissions, as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. This Working Group aims to identify and close specific gaps that prevent the FDA and industry from optimising the use of data standards.

Leads: Janet Low, Jane Owens & Sandy VanPelt Nguyen

Initiated in 2023, the Real World Evidence Working Group aims to support, address and answer pertinent questions around real world evidence. The Working Group is dedicated to sharing across the PHUSE Community (through Community Forums) and aligning on the best industry practices. By launching this as a new Working Group, we have a great opportunity to increase the areas within real-world evidence that we can discuss and develop content for, building on the excellent work that has already been done as a project as part of the Emerging Trends & Technologies Working Group.

Leads: Ashwin Rai, Parag Shiralkar & Berber Snoeijer

With a wider remit focused on RBQM, this Working Group will identify innovative approaches in the planning (Quality by Design, Critical to Quality, Risk Identification and Characterisation), conduct (Risk Control), and continuous improvement (Risk Review, Risk Communication) elements of RBQM that support proactive management data reliability and participant well-being. The Working Group will support the pharmaceutical industry with change management strategies related to embracing risk-based approaches.

Leads: Michael Walega, Jeremy Howells & Mireille Lovejoy

A cross-disciplinary collaboration working to improve the content and implementation of clinical trial safety analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.

Leads: Greg Ball, Mac Gordon, Scott Proestel & Ellis F. Unger