FDA Goals for Pediatric Clinical Trials

One study has estimated that 70% of the medicines given to children have only been studied in adults. Therefore,a majority of drugs administered to children today are used off label and without an adequate understanding of the appropriate dosage, safety or efficacy. The FDA supports the development and maintenance of a scientific and organizational infrastructure that can plan, initiate, conduct and close out pediatric clinical trials. Below are the goals set forth by the FDA to optimize the potential for successful pediatric clinical trials:

• Leverage basic science research on the causes of diseases to support the use of extrapolation from adult data
• Understand the maturation of metabolic pathways to be able to use modeling and simulation to optimize dosing strategies in pediatric patients
• Develop innovative trial designs and study multiple therapies at one time
• Leverage and standardize all sources of information including clinical trials, registries, natural history studies and electronic health records
• Develop multiple types of biomarkers for use in pediatric trials
• Develop clinically meaningful short and long-term efficacy and safety endpoints for pediatric trials

International Research Services, Inc. (IRSI) is a privately held clinical research company founded in 1977 by Stephen Schwartz, President and CEO. IRSI serves the cosmetic and pharmaceutical industries with a focus on dermatological safety and efficacy testing. IRSI is a leader in biophysical instrumental analysis of the effects of test products on human skin conditions. Additionally, IRSI has phase I-IV Rx and OTC trial experience in numerous other clinical indications including pediatric safety testing. For additional information, please call 914-417-4112 or 914-937-9483 or email info@irsi.org.