Advancing the Science of Study Endpoints

There are a number of unique challenges and considerations when using COAs with pediatric patients. While guidance documents provide a framework for pediatric COA assessment, this is a developing field of research. More information is needed to establish sound models for the development, validation, and implementation of COAs in pediatric clinical research. This session is intended to provide a forum for in-depth discussion of methodological challenges involved in the development and use of pediatric COAs, and the pursuit of solutions that are practical yet still adhere to established principles of instrument development.

“Pediatrics does not deal with miniature men and women, with reduced doses and the same class of diseases in smaller bodies, but….it has its own independent range and horizon…” Dr. Abraham Jacobi, 1889

Program Committee Representative: Jean Paty, Quintiles