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ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints
Session Chair(s)
Andrew Potter, PhD
Mathematical Statistician, OB, OTS, CDER
FDA, 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)
Frequently Measured Endpoints: Focus on Actigraphy Data
Bill Byrom, PhD
Signant Health , United Kingdom
Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Preliminary Considerations and Challenges When Formulating an Endpoint From Frequently Collected Patient-Reported Outcomes (PRO) Data
Rebecca Hager, PhD
FDA, United States
Mathematical Statistician, Office of Biostatistics, CDER
Endpoint Development Utilizing Digital Health Technologies
Elizabeth Kunkoski, MS
FDA, United States
Health Science Policy Analyst, OMP, CDER
Panel Discussion
Andrew Potter, PhD
FDA, United States
Mathematical Statistician, OB, OTS, CDER
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