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Registration for this year's Data Transparency (DT) Summer Event is open! The DT Event will take place 20–22 June and will feature thought provoking presentations from specially selected experts within the data sharing field. Click here to register for all three days. 

PHUSE are extremely proud to welcome the eighth PHUSE Working Group; Real World Evidence. The importance of this industry area has become increasingly apparent over recent years and the launch of this Working Group honours that. Working Group leads, Berber Snoeijer and David Hood, are looking forward to kicking off with exciting projects on real-world data sources, code and analysis techniques, and submission requirements. 

• Quality and Reusability of Real-world Data
• Real World Evidence Guidance
• Submitting Real-world Data 

To volunteer for one or more projects within the new Real World Evidence Working Group, email workinggroups@phuse.global. 

The Safety Analytics Working Group will be delivering a series of virtual, free to attend webinars over the coming months. The first webinar will be on Scientific Evaluation of Safety Data and Aggregate Safety Assessment Planning for IND Safety Reporting and will be held on 15 June (15:00-16:30 BST). Click Here to Register.

The RWE Working Group will be hosting a community forum on Designing your RWD Study: Is Your Data Fit For Purpose? This Community Forum will take place on 6 July , 14:00–15:00(BST)/09:00–10:00 (EST). Please email workinggroups@phuse.global to register!

The Comparing Analysis Method Implementations in Software (CAMIS) project, part of the Data Visualisation & Open Source Technology Working Group, have written a White Paper and are calling for your feedback! Explore this guidance document which identifies key considerations when understanding differences in statistical methodology implementations across programming languages. As the pharmaceutical industry increases their use of open source languages for clinical reporting, there is a vital need for discrepancies between open source languages and legacy software to be identified and documented. To avoid duplication of efforts across the industry, the CAMIS project has created a central GitHub repository to store these differences. This white paper highlights the importance of clear specification of statistical methodology in our documentation and calls for community collaboration to populate the repository with explanations of any known differences. Please submit your feedback to workinggroups@phuse.global by 12 June.

The SEND Industry Feedback Survey project, part of the Nonclinical Topics Working Group, are calling for your feedback on their 2023 survey! The aim of the survey is to expand on the results from last year’s topics and determine the reasons for the majority of respondents making manual edits and what solutions, such as automation, are being used to address them. Results of the survey will be presented at the PHUSE/FDA CSS. Please complete the survey by 19 June.

Patient foundations frequently develop and run patient registries, but deciding on the strategy, such as which data to collect and how to make sure it’s useful and meaningful, can be a challenge. The PHUSE project 'Best Data Practices for Rare Disease Patient Foundations and Researchers' was established to develop best data practices for patient foundations and researchers who work with them, inform industry of the registries run by patient communities, and build bridges between patients and industry, which will result in better data and inclusion of the patient voice into drug development. See all resent deliverables below. 

• Myths VS Facts About Patient Registries
  
• Patient Registry Transparency Checklist For Patient Foundations
  
• Patient Foundations Guide to Starting a Registry

The Real World Evidence (RWE) Working Group’s recently published White Paper: ‘Requirements and Recommendations for Regulatory Submissions’.

The previous RWE Working Group released their first White Paper: ‘Basic Considerations for the Use of Real World Evidence in Support of Regulated Clinical Trial Submissions’ in July 2020. Since then, the inclusion of real-world data in regulated clinical trials has gained significant prevalence. During the PHUSE/FDA Computational Science Symposium 2021, it became clear that companies are still insecure about the use of real-world data for regulatory submission trials due to lack of clear guidelines and standards. Since then, the FDA have released a number of draft guidelines on the use of real-world data for public review, which is discussed in this White Paper. It serves as a reference for relevant guidelines and articles related to the use of RWD/RWE for regulatory submissions.

Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements: 

• The projects must address significant research issues relevant to Computational Science
• The project must not attempt to address FDA policy issues
• There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit.