Clinical Trial Designs for Immunogenicity Assessments
Time: 11:30 am
day: Day 1- Clinical 1
Details:
• Include endpoints for evaluating immunogenic adverse events in clinical trial protocols and statistical analysis plans
• Develop robust systems for the collection and medical assessment of immunogenic adverse events during clinical trials
• Identify clinically significant immunogenic adverse events in participants, both with and without anti-drug antibodies (ADA)
