Cori Vanchieri, Adrienne Stith Butler, and Andrea Knutsen, Rapporteurs; Forum on Drug Discovery, Development, and Translation; Institute of Medicine
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent--have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Marilyn J. Field and Thomas F. Boat, Editors; Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Institute of Medicine
Theresa Wizemann, Bruce M. Altevogt, and Anne B. Claiborne, Rapporteurs; Forum on Drug Discovery, Development, and Translation; Forum on Medical and Public Health Preparedness for Catastrophic Events; Institute of Medicine
Peter C. Adamson, Susan L Weiner, Joseph V. Simone, and Hellen Gelband, Editors, Committee on Shortening the Time Line for New Cancer Treatments, Institute of Medicine and the National Research Council