Process for Aggregate Assessment of Clinical Trial AE Data

• Define the challenges and processes needed for aggregate AE assessment and identification of safety signals within early development programmes

• Research types of analytics that may be appropriate to implement, and the challenges they bring

• Bring clarity to ‘significance’ in safety without statistical connotation. Define important terms (medically important, clinically relevant, etc.)

• Delineate potential pitfalls with small sample sizes, limited important events and uncertain background rates

• Understand current organisational trends regarding safety assessment practices through the collection of focused survey results

Mac Gordon, Johnson & Johnson

rgordon2@its.jnj.com

Peg Fletcher, MedAssessment

peg.fletcher@medassessment.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global