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Data Transparency: Call For Volunteers

The PHUSE Stakeholder Review of UK MHRA Clinical Trials Regulation Guidance project is extending its work and has a new opportunity to provide feedback on the ISRCTN Results System Prototype. This new registry is designed to align with WHO data requirements and UK clinical trial regulations, making results submission easier, more flexible, and more accurate, while ensuring access and re-use of trial results.

Background Information:

ICRCTN recently released information a few days ago for public review and comment regarding the new registry they are working on, and the results system prototype is open for review until the end of September. 

 The key principles of this results system is to comply with the World Health Organisation data requirements and UK clinical trial regulations, making results submission as easy as we can and provide flexibility for different study designs. Also to help researchers submit accurate and complete data, along with ease of access to this information and re-using the results. 

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global.

Real World Evidence: Call For Co Lead

We’re looking for a Working Group Lead for our Real World Evidence Working Group, which aims to support, address and answer pertinent questions within the industry. 

Working Group Scope

TheReal 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

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: 26 September. 

If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. 

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