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Table 3 Summary of the administration of the clinical trials

From: Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region

Items Definition All cases completed Not all cases completed p value
n = 95 n = 47
   n (%) n (%)  
Clinical trial with an agreed PIP Yes 18 (18.9) 13 (27.7) 0.24
Sponsor type Commercial 87 (91.6) 47 (100.0) 0.10
Clinical trial with substantial protocol amendments Yes 71 (74.7) 31 (66.6) 0.27
Clinical trial with no protocol amendments after starting trials Yes 41 (43.2) 20 (42.6) 0.94
Global interruptions of the clinical trial Yes NA 7 (14.9) NA
Clinical trial status
 Not authorized Yes NA 4 (8.5) NA
 Temporarily halted Yes NA 2 (4.3) NA
 Prematurely ended Yes NA 43 (91.5) NA
  1. p values; chi-square test for categorical variables
  2. Note: PIP pediatric investigation plan, NA not applicable. Not authorized: Pediatric trials for which a negative ethics committee opinion was issued. Since a trial with a negative ethics committee opinion cannot proceed, these are labeled as not authorized. Temporarily halted: A trial that has been temporarily interrupted
  3. Prematurely ended: A trial that has ended without completing all events described in the protocol. Reasons for a premature end can be related to lack of product safety or efficacy, or lack of feasibility of the trial