Table 1.
Trials design data
| Number | Percent | |
|---|---|---|
| Trial Phase | ||
| Phase 2 | 188 | 87.0 |
| Phase 2/Phase 3 | 3 | 1.4 |
| Phase 3 | 25 | 11.6 |
| Number of Arms | ||
| 1 | 107 | 49.5 |
| 2 | 83 | 38.4 |
| ≥3 | 13 | 9.7 |
| NR | 5 | 2.3 |
| Sample Size | ||
| 0 to 50 | 90 | 41.7 |
| 51 to 100 | 62 | 28.7 |
| 101 to 200 | 36 | 16.7 |
| 201 to 300 | 11 | 5.1 |
| 301 or more | 16 | 7.4 |
| NR | 1 | 0.5 |
| Interventional Model | ||
| Single Group Assignment | 116 | 53.7 |
| Parallel Assignment | 92 | 42.6 |
| Factorial Assignment | 1 | 0.5 |
| Crossover Assignment | 2 | 0.9 |
| NR | 5 | 2.3 |
| Treatment Allocation | ||
| Non-Randomized | 47 | 21.8 |
| Randomized | 86 | 39.8 |
| NR | 83 | 38.4 |
| Masking (Blinding) | ||
| Open Label | 187 | 86.6 |
| Single Blind | 2 | 0.9 |
| Double Blind | 25 | 11.6 |
| NR | 2 | 0.9 |
| Endpoint Classification | ||
| Safety/Efficacy Study | 109 | 50.5 |
| Efficacy Study | 75 | 34.7 |
| Safety Study | 4 | 1.9 |
| Bio-equivalence Study | 1 | 0.5 |
| Pharmacodynamics Study | 1 | 0.5 |
| Pharmacokinetics Study | 1 | 0.5 |
| NR | 25 | 11.6 |
| Primary Purpose of Trial | ||
| Treatment | 207 | 95.8 |
| Diagnostic | 3 | 1.4 |
| Health Services Research | 1 | 0.5 |
| Basic Science | 2 | 0.9 |
| Supportive Care | 1 | 0.5 |
| NR | 2 | 0.9 |