Pediatric Drugs

, Volume 17, Issue 1, pp 83–90 | Cite as

Pediatric Clinical Drug Trials in Low-Income Countries: Key Ethical Issues

  • S. M. MacLeodEmail author
  • D. C. Knoppert
  • M. Stanton-Jean
  • D. Avard
Review Article
Part of the following topical collections:
  1. Ethics of Pediatric Drug Research


Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which will allow all those involved, and especially child patients, to benefit from the advancement of therapeutics.


Capacity Building Research Ethic Board Trovafloxacin Clinical Trial Unit Collaborative Partnership 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



No funding was received in support of this review. Stuart M. MacLeod, David C. Knoppert, Michèle Stanton-Jean, and Denise Avard have no conflicts of interest.


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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • S. M. MacLeod
    • 1
    • 5
    Email author
  • D. C. Knoppert
    • 2
  • M. Stanton-Jean
    • 3
  • D. Avard
    • 4
  1. 1.Department of PediatricsUniversity of British ColumbiaVancouverCanada
  2. 2.School of PharmacyUniversity of WaterlooWaterlooCanada
  3. 3.Centre de recherche en droit publicUniversité de MontréalMontrealCanada
  4. 4.Centre of Genomics and Policy, Faculty of MedicineMcGill UniversityMontrealCanada
  5. 5.AbercornCanada

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