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Problem Statement |
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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.
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Project Scope |
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- Define the different challenges and processes needed for aggregate AE assessment for development programmes with medium duration/low subject number, short duration/medium subject number, and long duration/high subject number.
- Delineate efficient standardised processes for each stage and identify where new technologies can strengthen the reliability of assessment.
- Delineate potential pitfalls when processes appropriate to one stage are applied to a different stage.
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| Objectives and Deliverables | Timetables |
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Assessment of Current Pharma Processes | 6–9 Months |
| White Paper | 1.5 Years |
| Webinars and Presentations | During White Paper Creation |
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- Ongoing updates from subgroups.
- Timelines from subgroups.
- ToC for white paper.
- Overall project timeline.
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