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Harmonisation in study design and outcomes in paediatric antibiotic clinical trials: a systematic review

Laura Folgori1, Julia Bielicki2, Beatriz Ruiz1

  • 1Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, UK.

The Lancet. Infectious Diseases
|July 5, 2016
PubMed

Insights

Antibiotic clinical trials in children lack global consensus and consistent regulatory guidance. Harmonizing definitions and outcomes through international collaboration is crucial for improving pediatric research and clinical practice.

Area of Science:

  • Pediatric Infectious Diseases
  • Clinical Trial Methodology
  • Regulatory Science

Background:

  • No global consensus exists for conducting clinical trials in pediatric patients with complicated infections.
  • Comprehensive regulatory guidance for designing pediatric antibiotic clinical trials is absent.

Purpose of the Study:

  • To systematically review antibiotic clinical trials in pediatric patients (0-18 years) with complicated infections.
  • To assess the application of European Medicines Agency (EMA) and US Food and Drug Administration (FDA) adult guidance in pediatric trials.
  • To evaluate the consistency of eligibility and outcome definitions in pediatric clinical trials.

Main Methods:

  • Systematic review of antibiotic clinical trials in bloodstream infections and community-acquired pneumonia in children and neonates.
  • Searched MEDLINE, Cochrane CENTRAL, and ClinicalTrials.gov (Jan 2000 - Nov 2015).
  • Analyzed 82 studies for adherence to CONSORT items, study design, eligibility criteria, and endpoints.

Main Results:

  • Published pediatric studies reported an average of 66% of CONSORT items.
  • Significant variation observed in study design, inclusion/exclusion criteria, and endpoints across studies.
  • Regulatory definitions from EMA and FDA for adults were variably applicable and utilized in pediatric trials.

Conclusions:

  • The absence of consensus in pediatric antibiotic clinical trials hinders research harmonization and clinical practice translation.
  • International collaboration among stakeholders is essential for harmonizing case definitions and outcome measures.
  • Standardized guidance is needed to improve the comparability of pediatric antibiotic therapies and strategies.

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