Regulatory Science Symposium: Bringing Drugs and Biologics to Market - Session 6: "Benefit/Risk Assessment"

Competencies: Benefits-Risks Assessment, Benefits-Risks Assessment Framework, Regulatory Science, Clinical Research and Regulations, Clinical Trials, Regulatory and Quality Sciences, Clinical Trial Quality

Course Syllabus/Topics

1. Benefits/Risks Assessments Diagram
2. FDA Premarketing B/R Assessment
   1. Risk collected as safety data, easier to collect premarketing
   2. Benefit is study/condition specific, related to endpoints, in relationship with risk
3. Benefits/Risk also vary by product category
   1. Innovator drug or biologic, generic drug, OTC
4. Adequate Risk Assessment for Marketing
   1. Important for sponsors to collect long-term safety data
5. US FDA Framework
   1. Standardized Framework for Benefits-risk assessment, include uncertainties
   2. Population, Product Characteristics
6. Activity/Workshop - Resources
   1. A look at FDA’s latest Publication on Novel Drug Approvals (published every year) > Select Product and Review Label
   2. Drugs@FDA website > Review Documents > Summary/Integrated Review > Benefits-Risk Framework
7. Future of Benefit/Risk Reporting
   1. Increasing reliance on real-world evidence for drug evaluations.
   2. Modern analytic tools, digital health technologies, and their impact on data quality
8. Real World Evidence (RWE)

Acknowledgements:
Accompanying text created by: Mahita Parasa, Student Worker; Karen Manrique, Program Administrator, SC CTSI (kmanriqu@usc.edu)