Table 4.
Executional design characteristics by phase
| Means (Coefficients of Variation) | Phase I | Phase II | Phase III |
|---|---|---|---|
| Number of Countries | 1.7 (0.86) | 6.1 (0.80) | 13.7 (0.64) |
| Number of Investigative Sites | 5.2 (2.52) | 35.1 (0.89) | 82.2 (0.69) |
| Number of Vendors | 4.4 (0.59) | 5.3 (0.55) | 5.6 (0.60) |
| Number of Planned Visits | 13.5 (0.58) | 18.3 (0.66) | 21.1 (0.76) |
| Number of Procedures per Visit | 14.5 (0.78) | 14.0 (0.53) | 13.5 (0.48) |
| Number of Patients Screened | 72.0 (1.03) | 442.5 (2.14) | 877.8 (1.20) |
| Number of Patients Enrolled | 46.9 (0.97) | 214.8 (1.05) | 589.1 (0.90) |
| Number of Patients Completing | 40.1 (0.98) | 157.1 (1.32) | 430.1 (1.23) |
| Number of Days for Follow-up | 56.4 (1.19) | 134.9 (1.34) | 87.2 (1.51) |