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Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials
Session Chair(s)
J. Jason Lundy, PhD
Principal
Outcometrix, United States
Panelists will discuss the rationale for using electronic data capture and provide methodological recommendations for preparing for the use of ePRO instruments in clinical trials. Challenges to the use of ePRO instruments in clinical trials will be discussed, and recommendations for overcoming these challenges will be provided. Real-world examples of the use of ePRO instruments in clinical trials will be used to illustrate the recommendations.
Learning Objective : Describe the rationale for collecting patient-reported outcome (PRO) data electronically; Define conceptual equivalence testing and statistical equivalence testing; Discuss challenges to the use of ePRO instruments in clinical trials.
Speaker(s)
Panelist
Elektra Papadopoulos, MD, MPH
AbbVie, United States
Director, Patient Experience Data and Strategy
Panelist
David S. Reasner, PhD
FDA, United States
Director, Division of Clinical Outcome Assessment, OND, CDER
Panelist
Keith Wenzel
DIA Study Endpoints Community, United States
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