22 FDA Case Studies with Divergent Phase 2/Phase 3 Results
22 Case Studies with Divergent Phase 2/Phase 3 Results
22 case studies of drugs, vaccines and medical devices since 1999 – No confirmation of:
- 14: effectiveness
- 1 : safety
- 7: safety and effectiveness
Why?
- Unexpected Results with Large Randomized Controlled Studies
- Presumed Mechanism of Action Does Not Automatically Predict Clinical Effects
- Biomarkers Do Not Reliably Predict Clinical Outcomes
