Satyendra Suryawanshi is director, clinical pharmacology and pharmacometrics, Bristol Myers Squibb.
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development
Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.