Time required for incremental steps in clinical trial initiation across participating sites
| Type of site; parameter | Overall; time, d | Research ethics board; time, d | Legal; time, d | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Protocol sent to site activation | Protocol sent to first patient enrolled | Site activation to first patient enrolled | Protocol sent to REB submission | REB submission to approval | REB approval to site activation | Protocol sent to contract submission | Contract submission to full contract execution | Full contract execution to site activation | |
| All hospitals | |||||||||
| Mean ± SD | 128.0 ± 99.6 | 151.3 ± 93.3 | 48.8 ± 54.5 | 44.8 ± 44.1 | 13.4 ± 29.4 | 65.1 ± 57.6 | 50.7 ± 49.7 | 43.3 ± 40.0 | 31.4 ± 45.1 |
| Median (IQR) | 111 (38.8–189.3) | 169 (53–232) | 32 (4–76) | 41 (10–56) | 4.5 (1–12) | 35 (22–103.5) | 42 (20.5–50.8) | 24.5 (15–57.8) | 10 (5.5–26.5) |
| Range | 15–412 | 14–358 | 1–210 | 4–195 | 0–169 | 0–239 | 4–237 | 5–164 | 0–216 |
| Academic hospitals,n = 26 | |||||||||
| Mean ± SD | 102.7 ± 94.4 | 109.7 ± 96.5 | 33.9 ± 47.8 | 24.5 ± 24.2 | 19.4 ± 39.0 | 52.4 ± 50.1 | 30.6 ± 22.4 | 38.7 ± 42.8 | 15.9 ± 21.0 |
| Median (IQR) | 68.5 (25.3–182.3) | 71 (27.5–218.8) | 5 (2.3–58.5) | 16 (5–38) | 5 (1–16) | 32.5 (13.3–93.5) | 41 (4–43) | 22 (15–40) | 8 (4–21) |
| Range | 15–392 | 14–266 | 1–140 | 4–84 | 0–169 | 0–160 | 4–82 | 5–164 | 0–73 |
| Missing | 0 | 4 | 4 | 6 | 6 | 0 | 9 | 9 | 1 |
| Community hospitals,n = 22 | |||||||||
| Mean ± SD | 158.3 ± 101.5 | 199.4 ± 66.3 | 65.9 ± 59.4 | 70.1 ± 51.9 | 5.8 ± 6.2 | 80.8 ± 64.1 | 73.5 ± 63.5 | 48.5 ± 38.9 | 49.0 ± 58.6 |
| Median (IQR) | 118.5 (91.3–192) | 206 (169–235) | 45 (24–103.5) | 51.5 (43–76.3) | 4 (1.8–8.3) | 60 (30–133) | 50 (42–84) | 49 (21–59.5) | 19.5 (8–87.5) |
| Range | 28–412 | 39–358 | 1–210 | 11–195 | 0–23 | 10–239 | 5–237 | 7–157 | 0–216 |
| Missing | 0 | 3 | 3 | 6 | 6 | 1 | 7 | 7 | 0 |
| Regional ethics submission sites,n = 4 | |||||||||
| Mean ± SD | – | – | – | – | 7 ± 4.9 | – | – | – | – |
| Median (IQR) | – | – | – | – | 7 (4–10) | – | – | – | – |
| Range | – | – | – | – | 1–13 | – | – | – | – |
| Missing | – | – | – | – | 1 | – | – | – | – |
Note: REB = research ethics board.