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The Estimands in Safety Analytics, a new project within the Safety Analytics Working Group, is now 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 will be 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 now 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.

  • With a clear process that defines approaches to the differing challenges of AE assessment in early development compared with Phase III, the overall end-user experience for internal and external stakeholders would be improved.

  • When related preferred terms are grouped together, it would be beneficial to have a consistent process for analysis plan documentation, SDTM/ADaM specifications, and analysis displays.

 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).

The Using OMOP and Other Real World Data Standards to Support Regulatory Submissions, a new project within the Real World Evidence Working Group, is now calling for volunteers. 

The project includes developing awareness of data standards specific to real-world data to support regulatory purposes. Common data models (CDMs) and taxonomies that are specific to the most commonly used real-world data sources by industry, member companies and regulatory bodies across the globe will be in scope, such as electronic health record sources, patient-reported outcomes, widely accepted claims data sources, and other commonly used observational data. OMOP and the OHDSI community will be the focus, and will be evaluated against other CDMs and standards (such as PCORnet, Sentinel and CDISC).

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 March.

The Kick-Off Meeting for this project will be held 6 March at 14:00-15:00 (GMT) / 9:00-10:00 (EST).

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