Table 2 Effect of surrogate outcomes on options for designing pivotal clinical trials
| 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 | ||
| Outcome | Hard | Surrogate | Surrogate | OS | PFS |
| Event rate | 100% experience event in 1 year | 100% experience event in 6 months | 100% experience event in 1 year | OS benefit demonstrated after 16 months of follow-up | PFS benefit not demonstrated until 19.3 months |
| Time to complete study | 1 year | 6 months | 1 year | 42 months between enrollment and results | 40 months between enrollment and results |