Paul O'Donohoe, Director of Health Outcomes, shares his perspectives on the impact of BYOD in clinical trials in 2016
Q: What is the current uptake of BYOD approaches within clinical trials?
Paul O’Donohoe: Currently BYOD has not made a big practical impact on the clinical trial space. The interest in BYOD, which is considerable at the moment, seems to be largely driven by anticipated savings in hardware costs as we’ll be taking advantage of the hardware patients have rather than provisioning devices. There is also a perception that BYOD will result in reduced burden for patients, due to the fact that they will be completing study questionnaires on a device they typically have with them for most of the day anyway, rather than providing them a whole separate piece of hardware.
While these are interesting arguments that certainly hold some weight, the actual impact is yet to be quantified in practice. Firstly, one will never have 100% saturation of suitable devices for completing study questionnaires in any sample of reasonable size. Thus there will always have to be some level of provisioned devices made available as we cannot exclude patients from taking part in a clinical trial because they do not own an expensive piece of hardware. The exact level of provisioning required is still an open question and will vary significantly based on the demographic and geographic distribution of the population. So, while some savings on hardware are obviously to be expected it will be far from a cost free exercise. Secondly, the reduction in burden BYOD will offer patients is, as yet, an open question. While it intuitively makes sense that patients would be more comfortable using their own, as opposed to an unfamiliar device, feedback from pilot testing at CRF Health suggests a significant number of participants may struggle with the basic functionality of installing apps on their own smartphone. Further, we currently have no data on the impact BYOD methodology will have on patient compliance. With compliance in provisioned eCOA studies already in the high 80 and low 90%’s we don't have much scope for it to get significantly higher.
So, while interest is in BYOD is high, there has been limited uptake in the Phase II or III space, with usage limited to medication reminders and other simple, objective data points. Regulatory concerns around equivalence of data reported across the range of different devices that could possibly be seen in a BYOD study has meant Sponsors have been reluctant to risk the approach on key endpoints. Phase IV studies have seen more uptake due to the fact that endpoints are often a bit "simpler" and regulatory requirements tend to be less stringent.
Q: What do you think will have the biggest impact on BYOD trials in the next year?
POD: I think the biggest impact will come from the industry continuing to answer some of the outstanding questions around BYOD, specifically those relating to equivalence and those relating to the logistics of ensuring all participants within a study have access to a suitable device. These answers will come from a number of sources, for example, individual research such as that CRF Health is involved in, or industry collaborations such as those being driven by the C-PATH Consortium. An additional powerful driver will come from sponsors going to the regulators with proposed plans for including BYOD as an element of a clinical trial to explore the practicalities of the approach in a “real world” setting. Regulators have indicated that they are open to the idea of BYOD and they recognize the potential benefits it could bring to a clinical trial, once they are provided reassurance on issues of equivalence and participants not being excluded for not having a suitable device. CRF Health is working with sponsors to generate answers to these questions and drive forward the field of eCOA.
Paul O’Donohoe is Director of Health Outcomes at CRF Health and is based in their London office. He is responsible for developing the company’s internal scientific expertise and supporting the scientific consulting being offered to clients.