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.





Mobile Devices in Medicine

There’s been a lot of interest in expanding the use of mobile electronic devices as a part of medical treatment. They’ve been in use in clinical trials (for Patient Reported Outcomes, or ePRO) for years starting with Palm Pilot devices with both good and bad results. A lot has been learned in that time; security and data integrity safeguards are improving. However, as devices get more powerful and more complex, new issues are being discovered…..even in the “Apple Magic Bullet” that is touted (and marketed) as being superior on that front. Case in point (Click Link for Full Article):

Germany warns of Apple security problem

By JUERGEN BAETZ, Associated Press Writer – 04 AUG 2010
BERLIN – Several versions of Apple’s iPhone, iPad, and iPod Touch have potentially serious security problems, a German government agency said in an official warning Wednesday.
Apple’s iOS operating system has “two critical weak points for which no patch exists,” the Federal Office for Information Security said.
Opening a manipulated website or a PDF file could allow criminals to spy on passwords, planners, photos, text messages, e-mails and even listen in to phone conversations, the agency said in a statement.
“This allows potential attackers access to the complete system, including administrator rights,” it added, urging users not to open PDF files on their mobile devices and only use trustworthy websites until Apple Inc. publishes a software update.

There’s enormous opportunity with new technologies, but a profround responsibility to be diligent in assessing them and protecting their data.