Table 1 National Surgical Adjuvant Breast and Bowel Project trial C-08 (NSABP C-08) interim monitoring bounds in terms of one-sided P -values
From: Predicting clinical trial results based on announcements of interim analyses
Interim analysis | Estimated time, years | Stop for futility if right-sided P-value < | Stop for superiority if left-sided P-value < | Number of events | Estimated accrual at interim |
|---|---|---|---|---|---|
1 | 2.0 | 0.05 | 0.00025 | 148 | 2,006 |
2 | 2.5 | 0.25 | 0.0005 | ~220 | 2,632 |
3 | 3.0 | 0.5 | 0.001 | ~312 | 2,632 |
4 | 3.5 | 0.5 | 0.001 | ~398 | 2,632 |
5 | 4.0 | 0.5 | 0.001 | ~473 | 2,632 |
6 | 4.5 | 0.5 | 0.001 | ~538 | 2,632 |
Final | 5.0 | N/A | ~0.0246 | 592 | 2,632 |