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Thursday, June 18 • 5:00pm - 6:00pm
#549 OD: ON DEMAND - Translating Frequently Collected Patient Experience Data into Meaningful Trial Endpoints

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Component Type: Forum
Level: Advanced

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 Objectives

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.


Andrew Potter, PhD


Bill Byrom, PhD

Rebecca Hager, PhD

Elizabeth Kunkoski, MS

avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, Signant Health
Bill leads product strategy and innovation, and the ePRO Science team at Signant Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →

Rebecca Hager

Mathematical Statistician, OTS, CDER, FDA
Rebecca Hager is a statistical reviewer in the Division of Biometrics III supporting the Division of Hepatology and Nutrition (DHN) in the Center for Drug Evaluation and Research (CDER) at the FDA. Rebecca joined the FDA in 2016 after receiving her Ph.D. in Statistics from North Carolina... Read More →
avatar for Elizabeth Kunkoski

Elizabeth Kunkoski

Health Science Policy Analyst, OMP, CDER, FDA, United States
Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in... Read More →
avatar for Andrew Potter

Andrew Potter

Mathematical Statistician, OB, OTS, CDER, FDA, United States
Dr. Andrew Potter is a mathematical statistician in the Division of Biometrics I in CDER supporting the review work in the Division of Psychiatry. His research interests include the use of digital health technologies in clinical trials and the analysis of high frequency outcome data... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum