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Session 10 Track A: Are PRO Measures Becoming Obsolete in the Digital Era?
Session Chair(s)
Paul O'Donohoe, MS, MSc
Senior Director, eCOA Product and Science
Medidata Solutions, United States
Investigators are increasingly seeking ways to use sensor data in clinical research. Some researchers have suggested that sensor data can be equivalent, or even superior, to similar data already being collected via patient-reported outcome (PRO) measures due to the perception that such data are an ‘objective’ measurement whereas PRO measures provide ‘subjective’ data and are thus, apparently, inferior or less reliable sources of information. This line of reasoning has led some to claim that PRO measures can, and will, be replaced by mobile sensors to measure symptoms and functioning in future clinical trials. This session will debate whether PRO measures are becoming obsolete and discuss ways in which these measurement tools are likely to be used in clinical trials moving forward. Panelists will represent industry, mobile technology expert, PRO researcher and FDA perspectives.
Learning Objective : - Summarize the pros and cons of using PRO measures and technology tools to assess endpoints in clinical trials
- Identify appropriate strategies for the implementation of various measurement tools for use as a clinical trial endpoints
- Understand the synergies different data sources can bring to understanding the patient experience in clinical research
Speaker(s)
Speaker
Sonya Eremenco, MA
Critical Path Institute, United States
Executive Director, PRO Consortium
Ieuan Clay, PhD
Digital Medicine Society (DiMe), Germany
Chief Scientific Officer
Speakers
Elizabeth Bush, MHS
Eli Lilly and Company, United States
Associate VP and Head, Patient-Focused Endpoints and Measurement
Speaker
Michelle Campbell, PhD
FDA, United States
Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER