Table 6.
Select protocol performance outcomes by phase
| Mean Duration Days and Mean Percents | Phase I | Phase II | Phase III |
|---|---|---|---|
| Total Clinical Trial Duration (Final Protocol to DBL) | 640.9 | 1027.9 | 1,327.7 |
| Study Initiation Duration (Final Protocol to FPFV) | 124.8 | 130.0 | 165.6 |
| Enrollment Duration (FPFV-LPFV) | 308.8 | 438.5 | 507.6 |
| Study Conduct Duration (LPFV-LPLV) | 172.0 | 315.8 | 462.0 |
| Treatment Duration (FPFV-LPLV) | 475.7 | 807.0 | 1,063.5 |
| Study Close-Out Duration (LPLV-DBL) | 57.6 | 65.2 | 57.2 |
| Time to Clinical Report (DBL-CSR) | 170.3 | 169.3 | 148.4 |
| Randomization Rate (Enrolled/Screened) | 67.7% | 69.4% | 70.7% |
| Completion Rate (Completed/Enrolled) | 77.8% | 70.5% | 67.6% |