Table 6.
Reporting of Interim Analysis Parameters in trials that mentioned Interim Analysis (n = 62)
| Parameter | Pediatric Journals (n = 22) |
General Journals (n = 40) |
|---|---|---|
| Number of formal interim analyses planned | ||
| Reported | 8 (36) | 23 (58) |
| Unclear or Not Reported | 14 (64) | 17 (42) |
| Number of formal interim analyses performed | ||
| Reported | 19 (86) | 33 (83) |
| Unclear or Not Reported | 3 (14) | 7 (17) |
| Parameter defining timing of interim | ||
| Reported | 18 (82) | 30 (75) |
| Unclear or Not Reported | 4 (18) | 10 (25) |
| Outcomes on which interim analyses were performed | ||
| Reported | 13 (59) | 32 (80) |
| Unclear or Not Reported | 9 (41) | 8 (20) |
| Statistical monitoring methods specified | ||
| Reported | 11 (50) | 22 (55) |
| Unclear or Not Reported | 11 (50) | 18 (45) |
|
Adjustment of results for interim analysis (p value, CI or estimate) |
||
| Reported | 2 (9) | 17 (43) |
| Unclear or Not Reported | 20 (91) | 23 (57) |
N (%)