The world's 1.89 billion children (age 0-14) too frequently receive treatments that have not been validated through clinical pharmacology research, especially in low- and middle-income countries. Initial findings from an international asset map of professionals and clinician scientists available to address the needs for education, research, and treatment support suggest a critical shortage of clinical pharmacologists, clinical pharmacists, and other professionals with advanced training in the evaluation of therapies for childhood conditions and illnesses. A total of 497 individuals responded to a survey conducted between May 2015 and February 2016. An alarming signal is apparent showing that, while the overall resource pool is unquestionably limited, 87% of relevant qualified personnel are located in high-income countries. The data suggest an urgent need for targeted training in pediatric clinical pharmacology, with particular focus on the needs in Africa, Latin America, and most of Asia.

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.

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