Pediatric Trials: The Impact of U.S. Legislative and Regulatory Efforts

It is not intuitive that scientists, clinicians, and parents would allow the most complex, constantly evolving human beings—the pediatric population—to be treated with unstudied medicines and therapies, while demanding a high level of evidence for therapies for the adult population. Unfortunately, this happened during the recent decades of rapid scientific and therapeutic discoveries. Why would it be acceptable that a population that is growing, developing, and inherently highly variable would not be studied while the more stable, not growing, and less variable adult population would be? No o­ne would argue that the 500- to 1000-gram infant is the same metabolically, physiologically or behaviorally as a preschooler or adolescent, much less a 70-kg adult. And yet we have prescribed, dosed and treated the pediatric population without pediatric studies of a drug's absorption, distribution, metabolism, elimination, or dosing, or without clinical trials to determine pharmacokinetics, pharmacodynamics, safety, and efficacy of the prescribed therapy.

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