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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**
  1. *Prevalence in each subgroup, for example, a control group is present in 26 of 42 exploratory trials (62 %)
  2. **Fischer’s exact test due to fewer than five observations in a single cell
  3. # n = 51, because compliance was considered “not relevant” in 27 exploratory and in 17 confirmatory trials