Back to Agenda
Developing Standard Core Clinical Outcome Assessments and Endpoints: FDA Perspective and Plans
Session Chair(s)
Meghana Chalasani, MHA
Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
This session will provide an opportunity for stakeholders to hear about FDA’s effort to advance the development of a publicly available core set(s) of clinical outcomes assessment measures and endpoints.
Learning Objective : Describe FDA efforts, including plans and progress on an anticipated new FDA extramural grants program, to advance the development of a publicly available core set(s) of clinical outcomes assessment (COA) measures and endpoints for specific disease indications; Discuss the opportunities for key stakeholders including, academia, Health Technology Assessors, payers, health care providers, and regulated industry.
Speaker(s)
Theresa Mullin, PhD
Associate Center Director - CDER, FDA, United States
FDA Update
Laura Lee Johnson, PhD
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
FDA Update
Elektra Papadopoulos, MD, MPH
Director, Patient Experience Data and Strategy, AbbVie, United States
FDA Update
Tara Symonds, PhD
Chief Science Officer, Clinical Outcomes Solutions, United Kingdom
Industry Update
Anton Hoos, MD, PhD, MBA
Executive Team, Patient Focused Medicine Development, Belgium
Industry Perspective
Have an account?