4.6 Article

Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study

期刊

JOURNAL OF PEDIATRICS
卷 184, 期 -, 页码 209-+

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MOSBY-ELSEVIER
DOI: 10.1016/j.jpeds.2017.01.071

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资金

  1. Swiss National Science Foundation [320030_133540/1]
  2. German Research Foundation [EL 544/1-2]
  3. Santesuisse
  4. Gottfried and Julia Bangerter-Rhyner-Foundation
  5. Brocher Foundation
  6. Canadian Institutes of Health Research
  7. Canadian Chiropractic Research Foundation
  8. Hamilton Health Sciences Foundation
  9. Academy of Finland
  10. Competitive Research Funding of the Helsinki and Uusimaa Hospital District
  11. Finnish Cultural Foundation
  12. Finnish Medical Foundation
  13. Jane and Aatos Erkko Foundation
  14. Sigrid Juselius Foundation
  15. Hamilton Health Sciences
  16. Swiss National Science Foundation (SNF) [320030_133540] Funding Source: Swiss National Science Foundation (SNF)

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Objectives To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs. Study design A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists. Results We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants). Conclusion Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure.

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