Breaking (into) BYOD: New Data from Industry Leadership
BYOD supporters are in luck: If you want to see the bring-your-own-device movement get better, there is new data showing that industry leaders aren’t as opposed to BYOD as you may think. Applied Clinical Trials recently published a study that surveyed lead eCOA providers (and those related) on their opinions. mProve Founder and CEO Jeff Lee coauthored the article with Bill Byrom of ICON and other thought leaders within ICON and Medidata.
The authors lead a growing effort to push the BYOD concept forward and begin using it in mainstream clinical trials. The movement has been stalled for years at what Lee calls “the BYOD stalemate”: the FDA cannot issue any statements on the validity of BYOD-sourced data without seeing drug studies that use it; conversely, pharma companies are unwilling to risk the success of their clinical trials on a data collection method that the FDA hasn’t rubber-stamped. Byrom and Lee are some of the BYOD proponents trying to break through the red tape.
To shed light on the industry climate, the authors report on a survey taken by several dozen professionals at CROs, eCOA vendors, and biopharmaceutical companies. The survey asked a series of questions about some of the doubts surrounding BYOD: that subjects may lose or change their device, that the data collected may not be private, that site staff would be burdened, that the patient would delete or corrupt the app, etc.
For those who answered, around 70% were unconcerned or “a little concerned” about device change or loss. A similar number were relatively unconcerned about security/privacy issues with the data. The largest concerns for the group surrounded increased site effort and patients’ ability to disable study notifications on their device. The latter is a concern even with provisioned devices, as we can’t stop patients from intentionally throwing their phones into a drawer or leaving them out of earshot. The concern that BYOD may create more work for the sites is absolutely a valid one. Anticipating this, the authors suggest that good planning and app design can minimize the issue.
Also encouraging is the relative ambivalence toward extensive measurement equivalence testing. Given the large amount of hand-wringing over modality equivalence and validated data, one might expect the eCOA leaders to be extremely concerned about the equivalence of surveys completed across different devices. On the contrary: “over half of the respondents in our survey neither agreed nor strongly agreed that testing was required on all possible devices; and over half agreed or strongly agreed that demonstrating equivalence on a single device was acceptable if all subjects could be guaranteed to use a device of at least that minimum screen resolution and size.”
Byrom et al. go on to note that increasing evidence of paper and electronic equivalence is an excellent indicator, as the jump from paper to screen should be much more dramatic than the jump between slightly different screen sizes. They also point to existing studies demonstrating measurement equivalence over many electronic modalities.
Lee reports that this study is just part of a larger strategy to assuage industry skittishness toward BYOD. Even more equivalence testing is being done by Byrom and the ICON team, and best practices will need to be established to lock down app security and mitigate other risks. The cost benefits to the sponsor and the convenience benefits to the patient—and benefits that BYOD will then bring to the science itself!—are likely greater than any fallout from the BYOD model.
Read the full article here: http://www.appliedclinicaltrialsonline.com/bring-your-own-device-trial-outcome-assessment.