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Hyatt Regency Bethesda

Oct 05, 2015 12:00 PM - Oct 06, 2015 6:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Advancing the Science of Study Endpoints

Pediatrics

Session Chair(s)

Diane M Turner-Bowker, PhD

Diane M Turner-Bowker, PhD

Engagement Leader

Quintiles, United States

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

Speaker(s)

Diane M Turner-Bowker, PhD

8:15AM - 8:30AM - Welcome & Introduction - "Children are Not Just Miniature Adults"

Diane M Turner-Bowker, PhD

Quintiles, United States

Engagement Leader

Elektra  Papadopoulos, MD, MPH

8:30AM - 9:15AM - Concepts & Context: COA Measurement Strategies for a Pediatric Population

Elektra Papadopoulos, MD, MPH

AbbVie, United States

Director, Patient Experience Data and Strategy

Elizabeth Lauren Lindner

9:15AM - 10:00AM - Challenges Facing Sponsors in the Development and Use of COAs in a Pediatric Population

Elizabeth Lauren Lindner

Sucampo Pharma Americas, United States

Clinical Trial Manager, II

All  Participants

10:00AM - 10:30AM - Networking Break

All Participants

United States

Gina  Calarco, BSN, MPH

10:30AM - 11:15AM - Implementing COAs in Pediatric Clinical Trials

Gina Calarco, BSN, MPH

Covance, United States

Director of Pediatric Strategy and Planning

Panel  Discussion

Panel Discussion

Panel Discussion

United States

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