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Data Transparency Winter Event 2025 |
Active since 2014, PHUSE’s Data Transparency Working Group has provided subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate) and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength to strength. These virtual events have created an unrestricted space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions alongside experts in the data-sharing field. The PHUSE Data Transparency Autumn PHUSE Data Transparency Winter Event took place on 4–6 February 2025. Data Transparency Events offer you the chance to gain knowledge and experience from a wide data transparency community, allowing you to come together with experts from a variety of companies and backgrounds. During this virtual event, presentations were delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There was also a panel discussion and Q&A session focused on the day's themes. Links to the event presentations and daily recordings can be found /wiki/spaces/WEL/pages/91979777. |
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Announcement - Emerging Trends and Technologies Working Group Has Changed its Name! |
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There’s been an exciting change in PHUSE Working Groups recently… The Emerging Trends and Technologies Working Group has officially evolved into the Emerging Trends and Innovation Working Group! Why the change? Working Group Lead Mike Hamidi shares what brought about this change of name and scope: "The name change from Emerging Trends & Technologies to Emerging Trends & Innovation reflects a broader focus beyond technological enablement. This shift encompasses ongoing developments in areas such as AI/ML, digital health technologies and healthcare standards and aims to provide deeper insights into these and other evolving topics. This adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights and innovations.” PHUSE is We are equally excited to welcome Mark Bynens, the new Working Group Lead. He joins Mike Hamidi and Stuart Malcolm, expanding the team’s expertise and capacity. Mark Bynens brings a wealth of experience as Director and Scientific Computing Operations (SCO) Head within Statistics & Decision Sciences (SDS), Global Development at Johnson & Johnson. Mark leads initiatives in change management, project management, education, high-performance computing, and statistical research. Learn more about the Working Group Leads and their efforts here. Would you like to get involved in Working Groups? Check out the new Advance Hub page to view all opportunities. |
Working Group Quarterly Report
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Well done to all our Working Groups who have had a fantastic 2024!
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published two new FAQs! They have answered a FAQ with Data Submission, the FAQ answered looks at the ‘Correct Implementation of the Define-XML Standard for Submission Purposes – ADaM and SDTM Variable Alignment’ and ‘Correct Implementation of the Define-XML Standard for Submission Purposes – Clarifications Needed’. You can view this question and see the FAQ's this project has answered so far here. Do you have a SDTM ADaM Implementation FAQ question? You can send your questions to the team by emailing workinggroups@phuse.global. |
The Submitting Real World Data project within the Real World Evidence Working Group, has published a Blog. This Blog post explores possible approaches for submission of real world data to regulatory bodies. Real world data, as defined by the Food and Drug Administration in their guidance, comprises data collected from non-interventional study designs. (1) From project group discussions, ‘claims’ and ‘electronic health records’ comprise most real world data used in providing clinical evidence. Fast Health Interoperability Resources, or FHIR, is a platform used by HL7 for health information exchange. (2) This platform is widely used to exchange healthcare information, as far as claims and EHR data is concerned. As a result, a significant portion of real world data used by the pharma/biotech industry follows HL7-FHIR. |
The AE Groupings in Safety (AEGiS) project within the Safety Analytics Working Group has published a new white paper. This white paper outlines why using standard AE groupings for queries is key to understanding a drug’s safety profile, discusses assumptions underlying the use of standard queries for estimation and outlines the benefits of standard queries when available. When standard queries are not available, but detailed analysis of a specific medical condition is needed, this document recommends a process to develop and maintain a custom query that can be replicated by regulatory authorities. |
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The Estimands in Safety Analytics, a new project within the Safety Analytics Working Group, is calling for volunteers. The value of well-defined safety estimands is not generally appreciated and has not been communicated well to safety scientists.
Safety analyses are often ambiguous and, in some cases, carry the risk of being misinterpreted.
A better understanding and consequently a more consistent application of a robust estimand framework in the analysis of safety data would eliminate this ambiguity and drive clarity on both the specific question an analysis addresses, as well as the answer to that question.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 14 February.
The Kick-Off Meeting for this project was held on 18 February at 14:00-15:00 (GMT) / 9:00-10:00 (EST).The Process for Aggregate Assessment of Clinical Trial AE Data, a new project within the Safety Analytics Working Group, is calling for volunteers. The FDA’s 2021 draft update to the ‘Final Rule’ strongly supports aggregate assessment of clinical trial AE data, but provides little guidance on the best processes to use at different stages of development.
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 21 February. The Kick-Off Meeting for this project will be held 25 February at 16:00-17:00 (GMT) / 11:00-12:00 (EST). |
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