Table 2 Effect of surrogate outcomes on options for designing pivotal clinical trials
| Â | Traditional | Scenario 1: speed up drug approval | Scenario 2: increased market share | TDM-1 | Pertuzumab |
|---|---|---|---|---|---|
Population | Relapsed | Relapsed | Newly Diagnosed | 2nd line | 1st Line |
Market share of population | Small | Small | Large | Â | Â |
Outcome | Hard | Surrogate | Surrogate | OS | PFS |
Event rate | 100% experience event in 1Â year | 100% experience event in 6Â months | 100% experience event in 1Â year | OS benefit demonstrated after 16Â months of follow-up | PFS benefit not demonstrated until 19.3Â months |
Time to complete study | 1Â year | 6Â months | 1Â year | 42Â months between enrollment and results | 40Â months between enrollment and results |