Rational Therapeutics for Infants and Children Workshop Summary (2000) / Chapter Skim
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Editor's Summary
Editor's Summary
Pages 1-7
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, the federal regulatory body involved during the development, preclinical studies, and clinical trial phases of new drug discovery and testing with humans, requires that companies provide evidence of the safety and effectiveness of a product before marketing of that product. The protocols used to meet this requirement have been in effect for the last three decades and have historically been primarily confined to studies with adult populations.
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Completing clinical trials in children is yet another challenge, given the required long-term follow-up studies. Although the regulatory process encourages pharmaceutical sponsors to investigate drugs and biologics in studies with children and rewards them for doing so, until now the primary emphasis has been on the collection of data concerning drug kinetics and, to a lesser extent, dynamics in pediatric and aged individuals.
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The workshop focused on four major areas of importance for improving understanding of the development and testing of drugs and biologics in studies with pediatric populations, as well as facilitating future planning in this area: · how children are similar or dissimilar to adults with regard to physiology, drug metabolism, immunology, cognitive effects, and response to disease states and therapy, · the identification of new advances in biomedical science that are uniquely applicable to children and that could be applied to the development and testing of drugs and biologics in studies with children, · the special requirements in evaluating drugs and biologics in studies with pediatric populations, including an assessment of when and how safety and efficacy data can be used for children, and · an examination of the many legal and regulatory issues in evaluating new drugs and biologics in studies with pediatric populations, as well as interrelated social and ethical concerns. The following sections highlight major themes discussed in the workshop presentations.
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The results of studies with adults may not always be extrapolated to children because growth and development issues add a range of complicated variables to the already intricate realm of drug metabolism and pharmacodynamics. Studies of drugs for use in children must be designed to account for the complex developmental changes that can affect drug biodisposition and pharmacodynamics.
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Because of their distinctive properties, the use of biologics results in unique safety concerns that require different types of monitoring, such as for adventitious agents that occur as a result of treatment with the biologic, or for reactogenicity. There is some concern about therapeutic biologics because little is known about the long-term effects of treatment with such agents, especially their effects on developing children.
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For instance, a special consideration is informed consent and whether parental consent, the assent of the child, or both are required. FDA's new Pediatric Rule makes it more likely that children will receive improved treatment, because physicians will have more complete information on how drugs affect children and the appropriate doses for each age group (FDA, 1998e)
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EDITOR 'S SUMMARY 7 If it is concluded that this incentive program does work for the pediatric population and is worth the cost, it may encourage its application to other populations, such as pregnant women, elderly people, or minority groups. If it is applicable to these other groups, will it be at the expense of maintaining the program for children?
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