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 |