Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
309

Room Number:
251

Level:
Intermediate

Type:
Forum

Title:
Challenges and Recommendations Related to the Use of ePRO Instruments in Clinical Trials

Chair(s):
J. Jason Lundy, PhD
Assistant Director, Patient-Reported Outcome Consortium
Critical Path Institute, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Panelist
Elektra Johanna Papadopoulos, DrMed,MPH
Medical Officer, Office of New Drugs, CDER
FDA, United States

Panelist
David S. Reasner, PhD
President and Founder
Albemarle Scientific Consulting LLC, United States

Panelist
Keith W. Wenzel
Senior Director, Global Alliances
Perceptive Informatics, United States