Table 2.
Scientific design characteristics by phase
| Means (Coefficients of Variation) | Phase I | Phase II | Phase III |
|---|---|---|---|
| Total Endpoints | 15.6 (0.62) | 20.7 (0.62) | 18.6 (0.54) |
| Total Eligibility Criteria | 31.7 (0.30) | 30.9 (0.36) | 30.4 (0.37) |
| Number of Distinct Procedures | 29.0 (0.41) | 33.5 (0.32) | 34.5 (0.40) |
| Total Procedures Performed | 168.8 (0.86) | 259.7 (1.16) | 266.0 (0.90) |
| Non-Core Procedures as Percent of Total | 19.0% (1.11) | 26.1% (0.71) | 23.1% (0.81) |
| Total Protocol Pages | 86.7 (0.30) | 107.6 (0.37) | 115.9 (0.34) |
| Total Case Report Form Pages | 186.4 (0.75) | 163.5 (0.80) | 177.5 (0.87) |
| Total Datapoints Collected | 330,420 (1.99) | 2,091,577 (1.79) | 3,453,133 (1.56) |
| Total Data Sources | 3.7 (0.41) | 4.2 (0.40) | 4.0 (0.39) |