Table 3 Summary of the percentage increase in total FTE-years, FTE-years for statistics, data management and trial management, and non-staff costs between the adaptive over the non-adaptive version of each scenario
Scenario | % increase in total FTE-years, median (range) | % increase in statistics FTE-years, median (range) | % increase in data management FTE-years, median (range) | % increase in trial management FTE-years, median (range) | % increase in non-staff costs, median (range) |
|---|---|---|---|---|---|
1. Group-sequential design (n=6) | 3.9% (2.7%, 27.7%) | 9.4% (2.3%, 34.2%) | 4.8% (3.2%, 28.0%) | 2.4% (2.0%, 29.9%) | 0.8% (0.0%, 6.3%) |
2. Phase 2b dose-response (n=6) | 2.2% (0.7%, 17.5%) | 13.4% (4.6%, 21.9%) | 0.0% (0.0%, 6.6%) | 0.0% (0.0%, 20.8%) | 4.2% (0.0%, 8.2%) |
3. Phase 3 MAMS (n=5) | 3.0% (1.3%, 7.9%) | 16.7% (4.7%, 26.0%) | 9.6% (0.0%, 19.8%) | 0.0% (0.0%, 14.2%) | 0.8% (0.0%, 5.3%) |
4. Umbrella study (n=5) | 3.0% (1.0%, 34.2%) | 11.1% (5.0%, 27.6%) | 6.4% (0.0%, 25.0%) | 0.0% (0.0%, 41.7%) | 0.0% (0.0%, 8.3%) |
5. Sample size re-estimation (n=5) | 26.5% (0.8%, 38.9%) | 36.8% (2.9%, 56.3%) | 28.75% (2.9%, 39.3%) | 22.2% (0.0%, 34.6%) | 13.5% (0.8%, 19.0%) |