Electronic Clinical Outcome Assessments in Clinical Trials
One of the advantages of being a consultant is the opportunity to be exposed to many innovative startups in the Bay Area rather than being locked down in one company. In the short months since I decided to focus 100% on my business, I noticed many creative products and innovative ideas stemming from these young startups. One of my observation is that there appears to be an uptake in companies developing consumer products such as wearables and cameras with the intention of expanding their indications to be used as electronic clinical outcome assessment (eCOA) tools for clinical trials. Now, I haven't been living under a rock and I know that traditional large tech companies like Apple and Google have entered the digital health space, but I'm amazed at how many smaller companies are focused in this area too. Some companies mistakingly believe that they need to obtain FDA 510k clearance in order to commercialize their device. I would give them the traditional Regulatory Affairs response "it depends." It really depends on the indications and medical claims they wish to seek, otherwise their device can be classified as a monitoring device which has a lower regulatory burden.
One company that I came across at an expo had developed a cam monitor that can monitor an infant's breathing rate and movement using powerful sensors from their camera and capturing the data in your smartphone in real time. Initially I dismissed this as simply a novel consumer product, but a simple device like that can do wonders in clinical trials as a tool to monitor patient's responses to drug trials. Using real time video capture, it's a bit more reliable than manually entering the information in a diary. In a recent issue of FDLI's Update magazine, the author (Ball, F. et. al) noted many advantages of eCOAs that included:
no need for manual secondary data entry
direct transmission into an electronic database
alarm or reminder capabilities
time and stamp capabilities
real-time data recording and transmissions; and
remit data capture.
FDA understands the value of utilizing eCOAs and requires that there be guidelines for record keeping, maintenance and access as well as compliance with 21 CDR Part 11 with respect to electronic records and electronic signatures. There's also cybersecurity risks to be considered and HIPPA requirements as the data will likely contain patient's sensitive data.
With wearables such as the Apple Watch and Fitbit that can track and monitor body temperature, heart rate, etc., these ubiquitous devices can be adopted into clinical trials as an option to monitor clinical outcomes. There are concerns regarding the accuracy of the wearables in yielding data equivalency so the sponsor will need to validate the wearables prior to including them in their trials. For example, as a former Fitbit owner, I recall driving from the Bay Area to LA and it recorded over 1000 steps on my watch when I spent 7 hours planting my butt in car during the road trip. I'm sure that the newer devices are more accurate, but I sometime question the accuracy of the data being collected. Thus the need for the sponsors to validate the device for their use.
Clinical isn't my area of expertise, but I thought that this topic is interesting to share since I'm starting to notice many articles on BYOD (Bring Your Own Device) and eCOAs being creeped up and several small startups entering this niche arena.
Notes about the author:
Alex Chang is a Regulatory Affairs consultant and founder of BioDesign Regulatory Services, LLC. Alex held several roles in the medical device, diagnostics, pharmaceuticals and biologics industries since 2000. Alex began his career in Regulatory Affairs in 2003 and has been very involved with the regulatory community ever since 2012 with RAPS. His consulting company, BioDesign Regulatory Services, LLC was established in 2018.