title: Clinical trials in pediatrics: The drug delivery dimension.
abstract: The medical and drug delivery devices needs of children are quite different and unique when compared to that of adults. The practice of off label use and modification of adult devices for pediatric use is widespread. Attendant risk and adverse effects of such practices are poorly documented. Lack of pediatric age appropriate drug formulations constitutes a major impediment to pediatric drug labeling. While novel drug delivery system can help circumvent some of the pediatric formulations issues, the inherent high cost of development, the small size of the pediatric market, and the ethical dilemma of enrolling children in non-therapeutic clinical trials continue to militate against pediatric drug labeling as well medical devices development. Over the past four decades, major breakthroughs and achievements in basic biomedical science have supplied unprecedented potential information for improving human health. The need for properly designed and conducted pediatric clinical trials along with new drug delivery devices has never been greater. However major issues, like slow transition of promising basic scientific discovery into clinical applications, heavy regulatory burden, limited pediatric pharmacology research infrastructure, spiraling costs of health care, disproportionate governmental funding of basic science research over clinical research, conflicts of interest, and shortage of properly trained clinical investigators and willing study subjects continue to constitute major impediments to pediatric clinical trials clinical trials. This paper will seek to review among other things, the current state of affairs and the structure of the pediatric academic research enterprise along with their relationship with the pharmaceutical industry. Impediments to successful implementation of clinical trials in the academic setting will also be closely examined.
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center Cincinnati, Ohio, USA. bankole.osuntokun@cchmc.org
authors.forename: Bankole
authors.initials: B
authors.lastname: Osuntokun
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic / Q000592:standards; D016503:Drug Delivery Systems / Q000295:instrumentation / Q000592:standards; D006801:Humans; D010372:Pediatrics