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Advancing the Science of Study Endpoints
Session 1: Current Payer Perspective on the Value of Study Endpoints
Michael Lees, MA
- Chief Operating Officer and Head of Market Access Strategy
- PHMR Ltd, United Kingdom
This session will describe, from the perspective of 2-3 international payers, the value of study endpoints in making decisions on access to medicines. While highlighting differences between the needs of different jurisdictions and the different emphasis placed upon study endpoints in these jurisdictions, there will be an attempt to find similarities between the different jurisdictions. The session will close with a discussion on likely future requirements for study endpoints from each of the payers included.
Learning Objective : Upon completion of this session, participants should be able to:
- Define requirements for study endpoints and the relative importance in access decision-making compared with other factors
- Differentiate between those endpoints that drive decision-making in each jurisdiction and those that illustrate value without driving decision-making
- Identify future requirements for study endpoints that will drive access decision-making across different jurisdictions
Registry of Patient Registries (RoPR) Outcome Measures Framework (OMF) Clinical Harmonization
Elise Berliner, PhD
- Director, Technology Assessment Program
- Agency For Healthcare Research and Quality (AHRQ), United States
Core Outcomes: Consistent Evidence for Better Decisions
Donna Messner, PhD
- President and CEO
- Center for Medical Technology Policy (CMTP), United States