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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 %)
  1. *Prevalence in each subgroup; for example, 21 of 42 exploratory trials (50 %) showed overall consistency
  2. Based on the subgroup of 37 trials with a confirmatory protocol and more than one confirmatory published report