Medicine and healthcare, for all these years, have been evidence-based in the case of adults, and will continue to be so. However, the quality and efficacy of research in pediatrics are mostly based on anecdotal data and extrapolation of data from adult research. Over 50% of the medications used for children are used as 'off-label' and there have been no records of testing them in children. Over the years doctors have managed to administer estimated doses to children according to their body weight, but this can and has proven to be risky. In 1950, this nightmare came true - Chloramphenicol was used to treat infections in adults resistant to penicillin, but when the same was administered to babies they died, as their immature liver could not break down the drug efficiently. Since then, there has been this long standing debatable question of whether children should participate in clinical trials.

There have been numerous publications relating to the recruitment of adults in trials, but only a handful of them for children. There is a need for understanding that children differ from adults in their individuality, apprehension and biology. The differences between adults and children are based on their physiology, pathology, pharmacodynamics and pharmacokinetics. There are differences in their metabolic pathways, metabolic rates, receptor functions, effector systems and homeostatic movements. Age influences severity of the disease, pathological agents, natural history, dose of medication dependent on body weight and height. One size does not fit all; even among children there are different age groups. Pediatric clinical trials must be carried out with the focus on the novelty of the compound, uniqueness of the conditions in pediatrics, the age ranges of the children, unique safety concerns in pediatrics and the unique requirement of pediatric formulations that serve the needs of the population. Studies must be performed on different age groups such as premature newborns, full-term newborns, infants and toddlers, older children and adolescents

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