Perspectives in pediatric clinical trials: a review

Vihang S. Chawan, Sagar V. Badwane, Kalpesh V. Gawand, Abhishek M. Phatak, Sandeep S. Chaubey


Children are different from adults in many aspects of pharmacotherapy, including capacity to absorb, distribute, metabolize and excrete drugs and have their own taste preferences. International Conference on Harmonisation (ICH) guidelines classify pediatric age groups into five groups namely preterm, term new born infants, infants and toddlers, children and adolescents. United States conducts maximum number of pediatric drug trials as compared to developing countries. Most of the prescribed drugs are either unlicensed or have an off label use. That is these have not been evaluated for their safety and efficacy in children. As children are separate population entity and not mini-adults, these clinical trials with adults cannot be simply generalized or extrapolated to pediatric population. Thus it is mandatory to conduct clinical trials involving pediatric population in order to get full benefits to the children. To study this gap between adults and children for their wellbeing, disease prevention, diagnosis and treatment, high quality clinical trials are required.


Review, Child, Pediatrics, Clinical Trials, Informed consent, Pharmacology

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