207_Combined course Presentations

Later Stage Trials Biomarkers: Enrich or Stratify?

• Enrich = “integral” – Certainty about biomarker

• Stratify = “integrated”

– Bigger than no-biomarker trial – Assay clinically valid (less scrutiny)

– Certainty that you do not wish to test others – Assay clinically valid (FDA is watching you!)