Published Pediatric Randomized Drug Trials in Developing Countries, 1996–2002 View Full Text


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Article Info

DATE

2010-04

AUTHORS

Khairun N. B. Nor Aripin, Helen M. Sammons, Imti Choonara

ABSTRACT

BACKGROUND: The greatest burden of disease in children lies in the developing world; however, previous reviews have suggested that few randomized controlled trials (RCTs) involving children take place in developing countries. Children in developing countries deserve the same standard of medicines as those in developed countries, i.e. appropriate medications for the specific diseases that occur. OBJECTIVE: To elucidate published pediatric therapeutic RCTs that have taken place in the developing world and to determine whether they are appropriate for the major diseases occurring there, and to explore their approach to safety monitoring. METHODS: A previously assembled database of pediatric RCTs published between 1996 and 2002, from journals indexed in MEDLINE, was analyzed. The main country of setting of the RCTs was categorized as having low, medium or high development status according to the Human Development Index (HDI). Articles were read to add the WHO International Classification of Diseases 10th Revision (ICD-10) category of the disease studied, the WHO Collaborating Centre for Drug Statistics Methodology Anatomical Therapeutic Chemical (ATC) classification system category of the main drug therapy studied, the source of funding, and ethical approval to the variables already recorded in the database. RESULTS: One hundred and fifty-eight (22%) of the 733 RCTs analyzed took place in medium and low HDI (developing) countries. The disease areas studied seemed appropriate, with 89 (56%) of the 158 RCTs studying infectious and parasitic diseases. Ninety-nine (63%) RCTs from developing countries were trials of antiparasitic and anti-infective drugs. Compared with studies from high HDI countries, a significantly lower proportion of articles from medium and low HDI countries mentioned ethical committee or institutional review board approval, and safety monitoring. Only one paper from low and medium HDI countries mentioned the presence of a safety monitoring committee/data safety monitoring board. CONCLUSIONS: Published pediatric drug RCTs conducted in developing countries appear to study appropriate diseases but the results show that fewer RCTs are undertaken compared with the developed world. The standard of reporting for RCTs from developing countries needs attention to ensure that adequate information can be obtained, especially with regard to safety monitoring. More... »

PAGES

99-103

References to SciGraph publications

  • 2005-04. Clinical trials of medication in children, 1996–2002 in EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
  • 2007-11. The Morally Uncomfortable Global Drug Gap in CLINICAL PHARMACOLOGY & THERAPEUTICS
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.2165/11316260-000000000-00000

    DOI

    http://dx.doi.org/10.2165/11316260-000000000-00000

    DIMENSIONS

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/20218746


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