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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints

Session Chair(s)

Andrew  Potter, PhD

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)

Bill  Byrom, PhD

Frequently Measured Endpoints: Focus on Actigraphy Data

Bill Byrom, PhD

Signant Health , United Kingdom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science

Rebecca  Hager, PhD

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

Elizabeth  Kunkoski, MS

Endpoint Development Utilizing Digital Health Technologies

Elizabeth Kunkoski, MS

FDA, United States

Health Science Policy Analyst, OMP, CDER

Andrew  Potter, PhD

Panel Discussion

Andrew Potter, PhD

FDA, United States

Mathematical Statistician, OB, OTS, CDER

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