Incentive to study drugs in children and other governmental initiatives: will patients with asthma benefit?
This article summarizes current regulations that have been developed to facilitate the performance of pediatric drug trials and their impact on children, particularly those children affected with asthma. In addition, other initiatives that have been developed by the federal government in response to the unexplained increase of asthma occurrence during the last 15 years will be reviewed. In the face of an asthma epidemic, a comprehensive approach is needed to determine the causes for the increase in the prevalence rate and the role of aeroallergens and other environmental and genetic factors and to identify effective preventive measures. Clearly, facilitating drug trials to prove the safety and effectiveness of drugs is of paramount importance.
Giacoia
G P
GP
Pediatric Pharmacology Research Unit Network, National Institute of Child Health and Human Development, Rockville, MD 20892, USA.
D000293:Adolescent; D001249:Asthma / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D015195:Drug Design; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D010372:Pediatrics / Q000331:legislation & jurisprudence*