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ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints
Session Chair(s)
Andrew Potter, PhD
Associate Director, Biostatics, United States
This forum will describe the challenges of determining clinically meaningful endpoints from frequently collected patient experience data. A panel will discuss considerations for translating this type of data into interpretable conclusions.
Learning Objective : Discuss issues regarding defining meaningful endpoints in light of more systematic and regular collection of patient experience data; Describe examples and identify considerations when formulating clinical trial endpoints.
Speaker(s)
Bill Byrom, PhD
Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
Frequently Measured Endpoints: Focus on Actigraphy Data
Rebecca Hager, PhD
Mathematical Statistician, Office of Biostatistics, CDER, FDA, United States
Preliminary Considerations and Challenges When Formulating an Endpoint From Frequently Collected Patient-Reported Outcomes (PRO) Data
Elizabeth Kunkoski, MS
Health Science Policy Analyst, OMP, CDER, FDA, United States
Endpoint Development Utilizing Digital Health Technologies
Andrew Potter, PhD
Associate Director, Biostatics, United States
Panel Discussion
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