Table 3 Overall consistency and discrepancy between protocols and corresponding published reports of academic drug trials by protocol-derived type of study, N = 95 protocols
From: From protocol to published report: a study of consistency in the reporting of academic drug trials
All trials | Exploratory trials | Confirmatory trials | ||||
|---|---|---|---|---|---|---|
n | % (95 % CI) | n | % (95 % CI)* | n | % (95 % CI)* | |
Number of trials | 95 | 42 | 53 | |||
Overall consistency | 37 | 39 % (29 to 49 %) | 21 | 50 % (35 to 65 %) | 16 | 30 % (18 to 43 %) |
Individual discrepancies | ||||||
Type of study | 22 | 23 % (15 to 32 %) | 6 | 14 % (4 to 25 %) | 16 | 30 % (18 to 43 %) |
Primary objective | 19 | 20 % (12 to 28 %) | 12 | 29 % (15 to 42 %) | 7 | 13 % (4 to 22 %) |
Primary endpoint | 39 | 41 % (31 to 51 %) | 16 | 38 % (23 to 53 %) | 23 | 43 % (30 to 57 %) |
Hypothesis | - 17 | - | - | - | 5/37◊ | 14 % (2 to 25 %) |
Sample size calculation | - | - | - | - | 17/37◊ | 46 % (30 to 62 %) |