Table 2.
Examples of Phase II/III Trials With Design Parameters
| Phase II Analysis |
Phase III Analysis |
|||||||
|---|---|---|---|---|---|---|---|---|
| Trial | End Point | Type I Error (%)* | Alternative | Power (%) | End Point | Type I Error (%)* | Alternative | Power (%) |
| Conroy et al14 | RR | 5 | 10% v 24% RR | 92 | OS | 5 | HR, 0.70 | 80 |
| CALGB-80802 | PFS | 15 | HR, 0.67 | 90 | OS | 2.5 | HR, 0.73 | 90 |
| CALGB-30610 | Toxicity | 50 | NA | NA | OS | 2.5 | HR, 0.77 | 81 |
| GOG0182/ICON515 | PFS | 7.5 | HR, 0.75 | 93 | OS | 2.5/4† | HR, 0.75 | 90 |
Abbreviations: CALGB, Cancer and Leukemia Group B; GOG, Gynecologic Oncology Group; HR, hazard ratio; ICON, International Collaborative Ovarian Neoplasm; NA, not applicable; OS, overall survival; PFS, progression-free survival; RR, response rate.
*
One sided.
†
Typical type I error divided by four to account for the multiple comparisons of each of the four experimental arms with the control arm (ie, Bonferroni correction).