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Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis

Ashley M Yu1, Bannuya Balasubramanaiam1, Martin Offringa2

  • 1Doctor of Medicine Program, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.

Pediatric Research
|June 15, 2018
PubMed

Insights

Reporting of standard of care in pediatric clinical trials needs improvement. Current deficiencies in describing standard of care limit research reproducibility and may lead to wasted resources.

Area of Science:

  • Pediatric Medicine
  • Clinical Trial Methodology
  • Research Reproducibility

Background:

  • Standard of care in pediatric medicine varies significantly across treatment centers.
  • Evaluating new pediatric treatments requires comparison against the established standard of care.
  • The current study aimed to assess the reporting quality of standard of care control arms in pediatric clinical trials.

Purpose of the Study:

  • To evaluate the reporting completeness of intervention and standard of care control arms in published pediatric clinical trials.
  • To identify variations in terminology used to describe standard of care.
  • To assess the impact of reporting quality on research reproducibility.

Main Methods:

  • A systematic review of pediatric clinical trials published in 2014 was conducted.
  • The TIDieR (Template for Intervention Description and Replication) checklist was used to assess reporting completeness for both intervention and standard of care arms.
  • 214 trials were included, with duplicate assessment of reporting for completeness.

Main Results:

  • A total of 214 pediatric trials were analyzed across various therapeutic areas.
  • Inconsistent terminology was observed when describing the standard of care.
  • Intervention arms reported significantly more TIDieR checklist items (8.45) compared to standard of care arms (5.81), p < 0.0001.

Conclusions:

  • Significant deficiencies exist in the reporting of standard of care in pediatric clinical trials.
  • Improved reporting of standard of care is crucial to enhance research reproducibility.
  • Addressing these reporting gaps can help mitigate research waste in pediatric medicine.
Abstract

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