Considerations on the use of Mobile eCOA/ePRO Technology in Clinical Trials

I’m going to be providing this training internally at my company. I’m wondering if it is of interest externally as well….

The use of Electronic Clinical Outcome Assessments (eCOA) or Electronic Patient Reported Outcomes (ePRO) via mobile devices (smart phones, tablets, etc.) has been evolving and expanding in recent years. As an industry, we’ve conquered some of the early challenges experienced with the use of these devices in the clinic, usually on lower risk data and often with a paper backup process in place. However, as we move forward with increasingly complex devices and data collection schemas for higher risk efficacy/safety data the stakes have raised. Adding to this risk is the advent of adaptive trial design and increased time pressures in clinical research. New challenges have emerged that need to be considered and mitigated as we move forward with the promise these technologies hold in the improvement of trial design and data quality. This training is designed to enhance the understanding of professionals in all areas of clinical research (Clinical Operations, Monitoring, Clinical Scientists, Data Management, Biostats, Medical Writing, etc.)  and the service organizations that support them (IT, Procurement, Contract Management, Quality, RA, Safety, etc.) including Senior Leadership who drive the initiatives to adopt best-in-class tools and design.

Thoughts?

~TJK

 

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