ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
| Number of clinical trials (N=128) | |
|---|---|
| Clinical trial phase, n (%) | |
| Phase 2 | 6 (4.7) |
| Phase 2b | 2 (1.6) |
| Phase 2/3 | 5 (3.9) |
| Phase 3 | 115 (89.8) |
| Trial objective, n (%) | |
| Dose-ranging | 1 (0.8) |
| Efficacy and safety, PK | 1 (0.8) |
| Efficacy and safety, QoL | 2 (1.6) |
| Efficacy | 15 (11.7) |
| Efficacy and safety | 109 (85.2) |
| Randomization, n (%) | |
| Randomized | 126 (98.4) |
| Single-arm | 2 (1.5) |
| Blinding status, n (%) | |
| Blinded | 120 (93.8) |
| Open-label | 8 (6.3) |
| PRO endpoint status, n (%) | |
| Primary only | 16 (12.5) |
| Primary+secondary | 5252 (40.6) |
| Primary+secondary+exploratory | 21 (16.4) |
| Secondary only | 26 (20.3) |
| Secondary+exploratory | 13 (10.2) |
| Exploratory only | 0 (0.0) |
PK, Pharmacokinetics; QOL, Quality of Life
“Main endpoints” is when PRO is used as either a primary or secondary endpoint in studies.