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Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children

Natalie Pica1, Florence Bourgeois2

  • 1Department of Pediatrics, Harvard Medical School, Boston, Massachusetts; Boston Combined Residency Program, Boston Children's Hospital and Boston Medical Center, Boston, Massachusetts; and.

Pediatrics
|August 6, 2016
PubMed

Insights

Pediatric randomized clinical trials (RCTs) frequently face discontinuation and nonpublication, impacting research integrity. Funding sources, whether industry or academic, significantly influence these outcomes, affecting the availability of crucial findings for children.

Area of Science:

  • Clinical Trials
  • Pediatric Research
  • Medical Evidence

Background:

  • Trial discontinuation and nonpublication pose risks to research resources and medical evidence.
  • Pediatric trials are particularly susceptible due to inherent challenges in pediatric research.
  • Understanding the prevalence of these issues in pediatric randomized clinical trials (RCTs) is crucial.

Purpose of the Study:

  • To determine the prevalence of discontinuation in pediatric RCTs.
  • To ascertain the rate of nonpublication for completed pediatric RCTs.
  • To identify factors influencing discontinuation and nonpublication, including funding source.

Main Methods:

  • A retrospective, cross-sectional study design was employed.
  • Pediatric RCTs registered on ClinicalTrials.gov between 2008 and 2010 were analyzed.
  • Data were extracted from the registry and publication records.

Main Results:

  • 19% of pediatric RCTs were discontinued early, with patient accrual difficulties being the primary reason.
  • 30% of completed pediatric RCTs remained unpublished, affecting over 69,000 participants.
  • Industry-funded trials showed higher rates of discontinuation and nonpublication compared to academic-funded trials.

Conclusions:

  • Discontinuation and nonpublication are significant issues in pediatric RCTs, potentially wasting research efforts.
  • Funding source is a key determinant, with both academic and industry sponsors contributing to inefficiencies.
  • Addressing these outcomes is vital for improving the quality and completeness of pediatric medical evidence.
Abstract

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