Image result for FDA Logo

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


  • Unexpected Results with Large Randomized Controlled Studies
  • Presumed Mechanism of Action Does Not Automatically Predict Clinical Effects
  • Biomarkers Do Not Reliably Predict Clinical Outcomes

summary 1.JPGsummary 2.JPGLEARN


Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s