As part of the very successful two day eCOA Forum, held March 3-4 in New Brunswick, NJ, we ran a workshop exploring the current state of Bring Your Own Device (BYOD), and devised an imaginary future as a way of possibly understanding how we might move the concept forward in the field of clinical trials.
BYOD is an idea that has attracted a lot of attention in the last year, some of it rather overstating the possible benefits. Embracing this trend, and in order to tap into the arts and crafts abilities of our wonderful Forum participants, we began the session with a “Cover Story” exercise, where groups imagined a future in which BYOD had been “solved” and was a widely accepted solution for capturing data in clinical trials, so much so that a whole cover story of a magazine was given over to the wonders of this technology.
And what a future our participants envisioned! Seamless data capture across a range of devices, not just patients' own smartphones but also devices providing a whole host of physiological measures; regulatory chagrin at their slow acceptance of the future; bizarrely high compliance rates in clinical trials - all were suggested as possible outcomes.
While largely a way of getting people to think differently about the topic, the exercise was also important for emphasising the different areas that BYOD could possibly impact in clinical trials, beyond just the obvious patient and hardware issues that are constantly discussed.
Once these “best case scenarios” were presented to the group, the real fun began as we started to tear apart all of these wonderful visions of a BYOD world, coming up with every feasible objection to these positive ideas. Unsurprisingly, the consistent issues that arose again and again included the equivalence of data captured on a range of different devices, and how one would deal with patients who did not have a suitable device to provide study data.
As we began to dig into these issues in more detail and brainstorm ideas of how we might overcome the challenges, it became clear that as an industry we felt the issue of equivalence of patient data between different devices is not going to be a show-stopping concern. However what might be a significant challenge is convincing the regulators of this point of view.
It was suggested that a group like the C-Path ePRO Consortium, which brings together regulators, industry and vendors would be a good venue for exploring this issue and generating the evidence that regulators might need to accept data captured in a BYOD methodology. Another suggestion was for a brave sponsor to integrate an element of BYOD into a study (for example in one country of a multi-country vaccine study), and then examine the data compared to the other countries to see if there were any systematic issues.
Another major hurdle that was identified centered on successfully deciding how many provisioned devices to include in a study. No matter the levels of technological uptake, one is never going to have 100% saturation of a suitable smartphone in all patient populations. Thus there will need to be some amount of devices made available to provide to patients without an appropriate device (and not even considering the additional complication of patients who lose/break a device throughout the course of a study). It was felt that to begin with it would be hard to accurately guess at the number of provisioned devices needed, although an educated guess could be taken based on the country and target population age and socio-demographic status. Thus for early adopters of BYOD it might be necessary to have nearly 100% provisioned devices, with these numbers getting more refined (and hopefully far lower) as experience is gained.
The workshops were extremely engaging and left me feeling positive that the challenges faced in making BYOD a viable approach to capturing data in clinical trials (and there are a lot of them) can be overcome by this very creative industry.
What challenges and rewards do you expect to see from BYOD in clinical trials?