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A systematic review of paediatric randomised controlled drug trials published in 2007

Khairun N B Nor Aripin1, Imti Choonara, Helen M Sammons

  • 1Academic Division of Child Health, School of Graduate Entry Medicine and Health Sciences, University of Nottingham, Derby, UK. mgxknbn@nottingham.ac.uk

Archives of Disease in Childhood
|May 27, 2010
PubMed

Insights

Global pediatric drug trials are numerous, but quality and ethical reporting vary significantly by country. More high-quality, ethical trials are needed to ensure safe and effective medicines for all children.

Area of Science:

  • Clinical Pharmacology
  • Pediatric Research
  • Global Health

Background:

  • Randomized controlled trials (RCTs) are crucial for establishing drug efficacy and safety.
  • The pediatric population requires specific considerations in clinical trials due to physiological differences.
  • Understanding the landscape of pediatric RCTs is essential for improving evidence-based medicine.

Purpose of the Study:

  • To assess the current status of randomized drug trials involving pediatric populations globally.
  • To analyze the characteristics, methodological quality, and ethical considerations of pediatric RCTs.

Main Methods:

  • A systematic review of pediatric RCTs for medicinal products published in 2007 was conducted.
  • Searches were performed across Medline, Embase, and Cochrane Central Register of Controlled Clinical Trials using validated strategies.
  • Data collected included trial location, participant demographics, drug class, and methodological quality.

Main Results:

  • Over 600 pediatric RCTs were identified, involving more than 100,000 children.
  • A significant disparity was observed, with only 24% of trials conducted in low and lower-middle income countries.
  • Trials in lower-income countries exhibited lower methodological quality and less frequent reporting of ethical approval, despite focusing on infectious diseases.

Conclusions:

  • A substantial number of pediatric RCTs are underway worldwide.
  • Enhancing the quality and ethical standards of clinical trials is imperative.
  • Inclusive and diverse participation across all pediatric populations is necessary to build a robust evidence base for pediatric medicines.
Abstract

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