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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

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