If you’re reading this, it’s overwhelmingly likely that you have a smartphone, and possibly a fitness tracker. Digital Health Technologies (DHTs) like these can help us learn more about our own physiology, behavior, and function – and they can help clinical researchers, too. To get data from patients’ own devices that’s trustworthy for those purposes, however, isn’t as simple as saying “bring your own devices!”
So how can the “bring your own ‘device’” (BYOD) approach work successfully? This is the topic of a recent paper co-authored by Koneksa’s Chief Scientific Officer, Dr. Elena Izmailova, and colleagues from the Digital Medicine Society (DiMe), of which she is a co-founder.
“Considerations for Conducting Bring Your Own ‘Device’ (BYOD) Clinical Studies” is published in Digital Biomarkers, and is available in full here.
This paper was also selected for presentation at the recent DIA meeting in Chicago, where Maria McCarthy, Charmaine Demanuele, and Elena Izmailova presented its highlights and led a vigorous discussion that demonstrated significant interest from the biomedical community.
The proliferation of wearable sensors marketed to consumers has put the public at ease with using those tools, and their technical evolution has made it possible for their data to be used in clinical trials. This makes study participation far more convenient for patients. Moreover, it makes it possible to gather data (which could include activity, sleep, or vital signs) in a natural environment, eliminating the “white coat effect.”
However, opportunities and possibilities do not always equal realities. Often, there can be gaps between the ideal and the everyday, and there can be barriers to wide deployment. Significant progress has been made by Critical Path Institute’s eCOA Consortium in advancing BYOD trials by publishing best-practice documents. Nevertheless, there are still barriers to BYOD adoption.
Perhaps the main barrier is industry hesitancy. Case studies in the public domain are limited, and it’s not clear whether this mode of data collection will be acceptable to regulators. The eCOA consortium is building a database about ePRO BYOD data collection and the rates of success for regulatory submissions.
The challenges for bring your own wearable (BYOW), as opposed to ePRO BYOD, are similar and different at the same time. Similarly, wide adoption is hampered by a lack of examples and data to demonstrate the success rate for BYOW in clinical trials. However, the complexity of wearable sensor deployment is much greater than ePRO. The purpose of the above paper was to answer the latter challenge. Again, “Considerations for Conducting Bring Your Own ‘Device’ (BYOD) Clinical Studies” is published in Digital Biomarkers, and is available in full here.
It offers guidance to biomedical researchers what they should consider when using BYOD in clinical trials. In this case, the BYOD includes both a smartphone and a wearable sensor. The recommendations include:
- early identification and engagement with stakeholders to provide input on clinical trial design;
- study design, which includes informed consent and recruitment strategies;
- defining outcomes of interest, related endpoints, and appropriate technology selection;
- data management, which includes compliance and data monitoring;
- statistical considerations for data processing and analysis to meet regulatory requirements.
This paper gives practical recommendations on how to make BYOD happen – important, because BYOD deployment provides clear advantages over-provisioned devices, including participant familiarity with the technologies, reduced burden, faster enrollment, and higher quality data not hampered by the Hawthorne effect (when study participants modify behavior knowing they are being monitored).
At Koneksa, we have experience with both ePRO and wearable deployment in multiple clinical studies. Our experience shows that it is very important to understand patient needs and preferences. The choice between a BYOD or provisioned device should be carefully made, considering many factors, including patient population and geography.
BYOD is practical and feasible. However, not all devices are created equal, and it is vital to understand everything that goes into ensuring data reliability. We firmly believe in the potential of wearables to improve clinical trial data collection rate and quality, and work with study sponsors every day, bringing to bear our technical expertise and operational experience to make it happen.