Hot Topics

Community Forum: Getting the RWD We Need – From Both Sponsor and Regulator Perspectives

7 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)

Working Group Webinar: Exploring the Synergy of Generative AI and the Teal Framework in Pharma

10 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)

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. 

'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.'

Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. 

The Good Transparency Practices project has published a new Guideline. Good Transparency Practice (GTP) is a guideline developed by the 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.

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.

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: 30 September.

The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group has produced a White Paper 'Cloud Services, A Framework for Adoption in the Regulated Life Sciences Industry'.

This paper sets out guidance on developing effective cloud exit strategies in the regulated life sciences industry. It explores how organisations can safeguard data security and integrity, maintain business continuity, meet compliance requirements, manage risks, and prevent vendor lock-in. By planning ahead, companies can stay resilient, flexible, and prepared for both planned migrations and unexpected provider changes.

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 10 October

The Applying Advanced Data Privacy Methods to Real World Data (RWD), a new project within the Real World Evidence Working Group, is now calling for volunteers.  

The goal of this project is to develop a comprehensive, cross-disciplinary resource to support individuals and organisations in applying advanced privacy-preserving techniques to real-world data (RWD). Given the evolving landscape of privacy regulations and the increasing complexity of data sources – including integrating machine learning (ML), artificial intelligence (AI) and large language models (LLMs) into healthcare pipelines – this project will serve as a critical foundation for advancing privacy-preserving data integration frameworks for RWD.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 7 October. 

The Kick-Off Meeting for this project will be held on 8 October at 9:00-10:00 (EST) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)

We’re looking for a Working Group Lead for our Real World Evidence Working Group. 

Working Group Scope

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. Some of the questions we intend to address are:

• What are the requirements, technologies and processes needed to use real-world evidence as a source for data analysis?

• What are the requirements, technologies and processes needed to incorporate real-world evidence into clinical trials?

• What are the requirements, technologies and best practices needed to support the use of real-world evidence as part of regulatory submissions?

Current Projects

• Applying Advanced Data Privacy Methods to Real World Data (RWD)

• Estimands for RWD/RWE

• Missing Data Imputation in RWD Exploration of Multiple Techniques on Open-Source Data

• RWD Guideline for Programming and Analysis Processes

• Submitting Real World Data 

• Quality and Reusability of Real World Data

• Using OMOP and Other Real World Data Standards to Support Regulatory Submissions

Working Group Lead Roles and Responsibilities 

You can learn about the role and the responsibilities here. If you are interested in this role or have any questions, workinggroups@phuse.global. Closing date: 7 October.