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Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed

Dario Tedesco1, Mufiza Farid-Kapadia2, Martin Offringa2

  • 1Department of Biomedical and Neuromotor Sciences, University of Bologna, Via San Giacomo, 12, 40126, Bologna, Italy.

Journal of Clinical Epidemiology
|December 2, 2017
PubMed

Insights

Harm rates in pediatric clinical trials show no significant differences between more developed and less developed countries. However, overall data on harms in children remains very limited, indicating a need for more research.

Area of Science:

  • Pediatric clinical research
  • Global health equity
  • Medical intervention safety

Background:

  • Assessing comparative harm rates in pediatric randomized clinical trials (RCTs) between more developed countries (MDCs) and less developed countries (LDCs) is crucial for global health equity.
  • Existing data on adverse events in pediatric populations across different economic settings is limited.

Purpose of the Study:

  • To evaluate and compare the rates of clinically important harm outcomes in pediatric RCTs conducted in MDCs versus LDCs.
  • To identify any systematic differences in harm reporting between these settings.

Main Methods:

  • A meta-epidemiologic evaluation of systematic reviews from the Cochrane Database (up to June 2014) was performed.
  • Meta-analyses including pediatric RCTs from both MDCs and LDCs reporting severe adverse events (AEs), discontinuations due to AEs, any AE, and mortality were analyzed.
  • Relative odds ratios (RORs) and summary RORs (sRORs) were calculated to compare harm rates between the two country groups.

Main Results:

  • Only 1% of relevant meta-analyses included pediatric RCTs from both MDCs and LDCs.
  • Analysis of 26 meta-analyses revealed no major systematic differences in harm rates: sROR for severe AEs was 0.92, for discontinuations 1.13, for any AE 1.10, and for mortality 0.99.
  • Significant differences (≥2-fold) in ROR point-estimates were observed in 35% of the meta-analyses.

Conclusions:

  • No significant systematic differences in harm rates were found in pediatric trials between MDCs and LDCs.
  • The study highlights a substantial limitation in the available data concerning harms in pediatric populations globally.
  • Further research is needed to comprehensively understand and address potential disparities in pediatric medical intervention safety.
Abstract

Keywords:
Cochrane Database of Systematic ReviewsComparativeHarmsMeta-analysesMortalityPediatricsRandomized trials

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