title: Published pediatric randomized drug trials in developing countries, 1996-2002.
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.
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby DE22 3DT, UK. mgxknbn@nottingham.ac.uk
authors.forename: Khairun N B
authors.initials: KN
authors.lastname: Nor Aripin
authors.forename: Helen M
authors.initials: HM
authors.lastname: Sammons
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
mesh_terms: D002648:Child; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D003906:Developing Countries; D064420:Drug-Related Side Effects and Adverse Reactions; D006803:Human Development; D006801:Humans; D038801:International Classification of Diseases; D016239:MEDLINE; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D014944:World Health Organization
chemical_list: D004364:Pharmaceutical Preparations