Hot Topics

PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, email: workinggroups@phuse.global.

Good Transparency Practices – Project Co-Lead and Members

The project aims to define a set of best practices for data transparency and create a Good Transparency Practices guidance. The best practices will help ensure anonymised data is compliant with the legal requirements, as defined by regulators, as well as preserving as much data utility as possible. 

Rare Disease/Small Population Data Sharing – Project Members

The goal of this project is to develop a resource for individuals who are anonymising or supporting/facilitating the sharing of rare disease or low population data. The aim is to produce a white paper which provides guidance, recommendations and methodologies for the handling of data from rare diseases/small populations. Although this project may not result in a “perfect” document, the aim is to have something that will be a foundation for future work.

Treatment Emergent Survey

The PHUSE Treatment Emergent Definition project team has goals of reducing variation in treatment emergent definitions and better harmonizing industry practice.  The group developed a survey to collect input on various treatment emergence scenarios and it will play a key role in meeting their objectives. The survey launched in mid-August and to date the group have had approximately 230 respondents.  Unfortunately, though, only 1 person from a regulatory agency has participated so far. The group want to include more input from our regulatory colleagues before the survey closes on the 18th February and would appreciate your help with soliciting for more participants from the FDA. 

The BIMO project team has drafted together a BIMO Data Reviewers Guide Package which looks to help clarify sponsors consideration, deviations from the BIMO Technical Conformance Guide (TCG) and, in an effort to avoid the Information Requests that are currently issued by the agency to sponsors to describe inconsistencies. 

The team is respectfully calling for public feedback on the package which includes a BDRG template, completion guideline and examples. Before reviewing these documents, please read through the BDRG introduction and overview. Please submit any feedback to Workinggroups@phuse.global by February 15th using the BDRG review feedback tracker to log your comments.

• BDRG Template  
• BDRG Completion Guidelines  
• BDRG Example 1  
• BDRG Example 2  
• BDRG Example 3  

If you wish to view the extensive list of all PHUSE published deliverables, click here.