Table 1 Protocol characteristics of academic clinical drug trials by type of study
From: From protocol to published report: a study of consistency in the reporting of academic drug trials
Type of study | ||||
|---|---|---|---|---|
Total n (%) | Exploratory n (%*) | Confirmatory n (%*) | P | |
Number of trials | 95 | 42 | 53 | - |
Single/multicenter | ||||
Single center | 71 (75 %) | 31 (74 %) | 40 (75 %) | 0.85 |
Multicenter, national | 16 (17 %) | 8 (19 %) | 8 (15 %) | 0.78 |
Multicenter, international | 8 (8 %) | 3 (7 %) | 5 (9 %) | 1.00** |
Sponsor’s affiliation | ||||
Hospital | 83 (87 %) | 40 (95 %) | 43 (81 %) | 0.06** |
Medical practice | 8 (8 %) | 0 (0 %) | 8 (15 %) | 0.01** |
University or other | 4 (4 %) | 2 (4 %) | 2 (4 %) | 1.00** |
Good clinical practice (GCP) | ||||
Adherence to GCP | 33 (35 %) | 16/41 (39 %) | 17/53 (32 %) | 0.48 |
Missing (not stated in protocol or application) | 1 (1 %) | 1 (2 %) | 0 (0 %) | 1.00** |
GCP monitoring | 27 (28 %) | 12 (29 %) | 15 (28 %) | 0.89 |
Control of compliance | 29/51# (57 %) | 8/15# (53 %) | 21/36# (58 %) | 0.86 |
Control groups | ||||
Control group | 76 (80 %) | 26 (62 %) | 50 (94 %) | <0.001 |
Control group, historical | 0 (0 %) | 0 (0 %) | 0 (0 %) | - |
Endpoints, power and sample size | ||||
Statement of endpoints | 95 (100 %) | 42 (100 %) | 53 (100 %) | - |
Statement of one to two primary endpoints | 73 (77 %) | 23 (55 %) | 50 (94 %) | <0.001** |
Statement of sample size calculation | 65 (68 %) | 12 (29 %) | 53 (100 %) | <0.001** |
Statement of statistical methods | 72 (76 %) | 32 (76 %) | 40 (75 %) | 0.94 |
Funding | ||||
External funding granted or wanted | 61/83 (73 %) | 27/38 (71 %) | 34/45 (76 %) | 0.64 |
Missing (not stated in protocol or application) | 12 (13 %) | 4 (10 %) | 8 (15 %) | 0.54** |