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Table 4 Factors related to incomplete clinical trials (N = 138)

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

Variable

 

Adjusted OR

95% CI

Trial part of an agreed PIP

Yes

1.8

[0.7, 4.3]

Both

1.0

[0.1, 8.3]

No

1.0

Reference

Rare disease

Yes

1.2

[0.5, 2.7]

No

1.0

Reference

Clinical trials that included newborns or infants and toddlers

Yes

1.3

[0.5, 3.4]

No

1.0

Reference

Number of countries in which the trial was conducted

Increment of one country

1.3

[1.1, 1.5]

  1. Coefficient of determination; 0.09, Model goodness-of-fit; p = 0.007
  2. Note: PIP pediatric investigation plan, CI confidence interval, OR odds ratio