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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