Digital Technology in Clinical Trials

Session Chair(s)

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)