Table 5.
Executional design characteristics by TA and indication (Phase II and III only)
Means (Coefficients of Variation) | Oncology | Non-oncology | Rare diseases | Non-rare diseases |
---|---|---|---|---|
Number of Countries | 13.1 (0.70) | 8.4 (0.84) | 9.7 (0.83) | 9.6 (0.82) |
Number of Investigative Sites | 67.6 (0.91) | 54.2 (0.87) | 27.4 (1.49) | 63.9 (0.79) |
Number of Vendors | 4.4 (0.69) | 5.8 (0.52) | 5.6 (0.76) | 5.4 (0.53) |
Number of Planned Visits | 29.3 (0.66) | 16.0 (0.57) | 24.3 (0.46) | 18.7 (0.77) |
Number of Procedures per Visit | 11.9 (0.53) | 14.4 (0.49) | 12.1 (0.48) | 14.1 (0.51) |
Number of Patients Screened | 952.6 (1.93) | 548.3 (0.95) | 247.1 (1.61) | 713.9 (1.50) |
Number of Patients Enrolled | 431.2 (1.39) | 373.1 (0.96) | 223.7 (1.57) | 424.8 (1.05) |
Number of Patients Completing | 244.9 (2.60) | 291.1 (1.05) | 112.9 (1.85) | 317.4 (1.36) |
Number of Days for Follow-up | 331.1 (0.79) | 77.2 (1.31) | 214.8 (1.34) | 95.2 (1.26) |