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Digital Technology in Clinical Trials
Session 10 Track A: Are PRO Measures Becoming Obsolete in the Digital Era?
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
Sonya Eremenco, MA
- Executive Director, PRO Consortium
- Critical Path Institute, United States
Ieuan Clay, PhD
- Chief Scientific Officer
- Digital Medicine Society (DiMe), Germany
Elizabeth (Nicki) Bush, MHS
- Senior Advisor and Head, Patient-Focused Outcomes Center of Expertise
- Eli Lilly and Company, United States
Michelle Campbell, PhD
- Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
- FDA, United States
Preconference Short Courses
Digital Technology in Clinical Trials Resource Kit