Abstract
Children have historically been under-represented in drug trials with dosing, safety and efficacy extrapolated from clinical trial data in adults. This practice is largely inappropriate as children have unique differences in developmental drug pharmacokinetics and disease pathophysiology when compared with adults. Failure to account for these differences risks safety events or suboptimal efficacy. These concerns have long been recognized by regulatory authorities in the USA and the European Union and, over the past 15 years, important initiatives have created incentives and mandates to improve drug study in children. While successful, these initiatives have been costly. Looking forward, it will be important to refine incentive structures in order to optimize the cost–benefit relationship in pediatric drug development.
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