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Published pediatric randomized drug trials in developing countries, 1996-2002

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

  • 1Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby DE22 3DT, UK. mgxknbn@nottingham.ac.uk

Paediatric Drugs
|March 12, 2010
PubMed

Insights

Pediatric drug trials in developing countries focus on relevant diseases but are underrepresented. Reporting standards, especially for safety monitoring, require improvement for children

Area of Science:

  • Pediatric pharmacology
  • Global health research
  • Clinical trial methodology

Background:

  • The majority of childhood disease burden is in developing nations.
  • Few pediatric randomized controlled trials (RCTs) are conducted in these regions.
  • Children in developing countries require access to appropriate medications for prevalent diseases.

Purpose of the Study:

  • To identify pediatric therapeutic RCTs conducted in developing countries.
  • To assess the appropriateness of studied diseases and interventions for major health issues in these regions.
  • To examine the safety monitoring practices reported in these trials.

Main Methods:

  • Analysis of a database of pediatric RCTs published between 1996 and 2002.
  • Categorization of trial settings based on Human Development Index (HDI).
  • Inclusion of disease (ICD-10) and drug (ATC) classifications, funding sources, and ethical approval data.

Main Results:

  • 158 (22%) of 733 RCTs were set in low/medium HDI countries.
  • Studied diseases were appropriate, with 56% focusing on infectious and parasitic diseases.
  • Trials in developing countries showed significantly less mention of ethical approval and safety monitoring compared to high HDI countries.

Conclusions:

  • Pediatric drug RCTs in developing countries address relevant diseases but are fewer in number.
  • The reporting quality of RCTs from developing countries needs enhancement, particularly concerning safety monitoring.
  • Ensuring adequate safety data is crucial for pediatric drug trials in resource-limited settings.
Abstract

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