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Risk of bias in randomized trials of pharmacological interventions in children and adults

Yashwant K Sinha1, Jonathan C Craig2, Premala Sureshkumar3

  • 1Center for Kidney Research, The Children's Hospital at Westmead, Westmead, Australia.

The Journal of Pediatrics
|May 13, 2014
PubMed

Insights

Pediatric randomized controlled trials show a similar risk of bias compared to adult trials when matched for drug class and therapeutic area. This indicates no inherent difference in the capacity to conduct high-quality research between pediatric and adult studies.

Area of Science:

  • Clinical Trials
  • Pediatric Research
  • Pharmacology

Background:

  • Assessing the quality of evidence from clinical trials is crucial for informed medical decision-making.
  • Concerns exist regarding potential biases in randomized controlled trials (RCTs) involving pediatric populations compared to adults.
  • Understanding these differences is vital for advancing pediatric pharmacologic interventions.

Purpose of the Study:

  • To compare the risk of bias in pediatric pharmacologic RCTs with similar adult trials.
  • To investigate whether disparities in trial quality exist between pediatric and adult research.

Main Methods:

  • A systematic review and matched-pair comparison of pediatric and adult RCTs published in MEDLINE (January 2008-October 2009).
  • Trials were matched by drug class and therapeutic area.
  • The Cochrane risk of bias tool was employed for assessment.

Main Results:

  • Pediatric and adult trials exhibited similar characteristics, with adult studies more frequently conducted in Europe and published in specialty journals.
  • A significant proportion of trials, both pediatric and adult, had an unclear risk of bias for allocation concealment.
  • While initial analysis suggested a lower risk of bias in pediatric trials for random sequence generation and blinding, a sensitivity analysis indicated publication year as a confounder.

Conclusions:

  • When matched for key characteristics, pediatric and adult RCTs demonstrate comparable risks of bias.
  • Differences in reported bias are not attributable to variations in researchers' capacity to conduct high-quality trials.
  • The findings support the potential for high-quality evidence generation in pediatric pharmacology research.
Abstract

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