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Session 5: Addressing Multiple Stakeholder Needs with COAs and Endpoints Selection
Session Chair(s)
Michael Lees, MA
Chief Operating Officer and Head of Market Access Strategy
PHMR Ltd, United Kingdom
The objective of this session is to explore the needs of additional stakeholders when selecting endpoints for inclusion in clinical trials and observational research. Health technology assessment (HTA) agencies often have requirements for different endpoints when making decisions, and will often interpret the same endpoint in different ways. The speakers in this session will identify the endpoints required for HTA decision making, discuss how these differ from regulatory requirements, and explain how the incorrect choice of endpoint, patient population or study follow up can cause delays in patient access to medicines. Different perspectives will be provided and potential for greater future alignment between regulators and HTAs - and between different HTAs - will be discussed.
Speaker(s)
Choosing Endpoints (and Other Key Study Aspects) in Clinical Development: What Does HTA Require in Germany?
Michael Lees, MA
PHMR Ltd, United Kingdom
Chief Operating Officer and Head of Market Access Strategy
Choosing Endpoints (and Other Key Study Aspects) in Clinical Development: What Does HTA Require in the UK?
Pall Jonsson, PHD, MS
National Institute for Health and Care Excellence (NICE), United Kingdom
Programme Director - Data and RWE
Academic Perspective: How Can the Choice of Endpoints Targeted at HTAs Help the Assessment of Value?
Lynn D. Disney, JD, PHD, MPH
University of Maryland, United States
Dir of Research, PATIENTS Program Pharmaceutical Health Services Research Depart