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The Data Transparency Autumn Event.

16–18 September at 10:00-12:30 (EDT) / 15:00-17:30 (BST) / 16:00-18.30 (CEST)

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)

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 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 and 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 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: 20 September.

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)