Children are not just small adults: the urgent need for high-quality trial evidence in children.
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Klassen, T. P., Hartling, L., Craig, J. C., & Offringa, M. (2008). Children are not just small adults: the urgent need for high-quality trial evidence in children. PLoS Med, 5(8), e172. doi: 10.1371/journal.pmed.0050172.
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Children are often touted as being very important members of society because they represent our future. Optimizing their health outcomes has the potential for a huge impact on public health because children are at an early stage in the life trajectory. But it is often unclear how society allocates its resources or creates policies to ensure that it invests in children's health. The under-investment in pediatric clinical trials is a good example of how our resource allocation may be insufficient. Over half of the pharmacological interventions we use for hospitalized children are off-label or unlicensed drugs [1,2]. The challenge for clinical care is that health care providers may fail to use medications that are indeed effective, or conversely, continue to use ineffective medications, or even those that bring unintended harm. Child health care providers must often rely on evidence that has been generated on adult populations [3]. However, both the safety and efficacy profiles of medications may be significantly different for children than adults due to differences in developmental physiology, disease pathophysiology, or developmental pharmacokinetics and pharmacodynamics
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http://purl.org/coar/resource_type/c_6501 http://purl.org/coar/version/c_970fb48d4fbd8a85
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en