Solange Corriol-Rohou

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Solange Corriol-Rohou is senior regulatory affairs and policy director for Europe, CMO office and chair of AZ Paediatric Work Group Regulatory Excellence, AstraZeneca.

Articles

Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

Sebastian Haertter;S. Y. Amy Cheung ;Angela James ;Ashley Strougo ;Christina Bucci-Rechtweg;Jing Liu ;Meina Tao Tang ;Paulien Ravenstijn ;Raafat Bishai ;Satyendra Suryawanshi ;Solange Corriol-Rohou

March 16th 2021

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.