Process for Aggregate Assessment of Clinical Trial AE Data

Problem Statement

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.

Project Scope

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.

Project Leads	Emails
Mac Gordon, Johnson & Johnson	rgordon2@its.jnj.com
Peg Fletcher, MedAssessment	peg.fletcher@medassessment.com
Nicola Newton, PHUSE Project Assistant	nicky@phuse.global

Objectives and Deliverables	Timetables
Assessment of Current Pharma Processes	6–9 Months
White Paper	1.5 Years
Webinars and Presentations	During White Paper Creation

CURRENT STATUS Q4 2024
Project approved.

WORKING GROUPS

Process for Aggregate Assessment of Clinical Trial AE Data

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