Throughout the years, several practical problems have discouraged drug testing in children. These include the lack of a suitable infrastructure to conduct pediatric pharmacology research; the unforeseeable nature of some clinical responses in immature individuals; the possibility of unanticipated adverse reactions; the threat of effects on growth, development or health, long after the drug's administration, and difficulties predicting dose or concentration-response relationships by extrapolating data obtained in adults or experimental animals. Researchers and clinicians involved in pediatric drug development face daily challenges that include, but are not limited to the following: the need to obtain parental permission and/or the child's assent; ethical issues related to the conduct of non-therapeutic research in children; the lack of technology applicable to children; and the lack of incentives that would encourage pharmaceutical companies to study drugs in neonates, infants and children. There is a significant unmet need for pediatric therapeutic and diagnostic device development. In spite of these challenges, the NICHD is aware of the critical need to establish and maintain an environment in which safe and effective pediatric clinical and device trial activities can quickly be initiated and managed. The NICHD provides direct support for clinical research and clinical research networks that focus on particular diseases or public health issues. One of the goals of NICHD is to fund research to better understand the effects and effectiveness of pharmaceuticals on maternal and child health. Continued use of this Task Order mechanism will ensure that NICHD is able to contract quickly and efficiently to acquire experts with the ability to support studies relating to pediatric drug and device development.
