Abstract
Pharmacogenetics is a newly emerging research area confronted with obvious scientific and ethical concerns not only from an academic and social perspective, but also on a regulatory level.
An overview of ongoing and planned pharmacogenetic studies is needed to evaluate the current status and focus of research and to appraise the alignment of research themes relative to the unmet medical needs of the paediatric population.
The objective of this review was to explore the current status, limitations and perspectives of pharmacogenomic and pharmacogenetic clinical research in the paediatric population from an academic, regulatory and industrial perspective.
Results show a rather equal distribution of activities across the different research categories throughout the world. More than 50% of the research activities are related to exploratory studies aimed at establishing the connection between a given genetic trait and the risk associated with a pathology or disease.
Based on this situation, we advocate for more translational and conformational studies. Moreover, there is a strong need to give appropriate attention to the methodological requirements for clinical research, which lack the scientific and statistical rigour and make study findings unsuitable for clinical purposes and often impossible to interpret.
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