A few years ago BYOD (bring your own device) was just an IT buzzword, and now it’s a part of everyday conversation. It is quickly becoming a widely-used approach to utilizing technology, with 67% of companies now allowing BYOD in the workplace. Early adopters, saw the value and realized the benefits: reduced turnaround times, greater convenience and flexibility for employees, and overall better communication. These same benefits are now being applied in the clinical space.
In reducing cost of clinical trials, the BYOD approach is receiving a lot of attention. The assumption is that most people have a smartphone or laptop, and that trial subjects can possibly use their own devices in a clinical trial setting. Since a specific device does not have to be purchased for the patient, it makes sense that clinical costs should be lower. The BYOD approach also allows participants to use devices that they are already familiar with and allows for real-time data collection and reporting.
There are of course challenges to adopting this method. An informal survey by Medidata, found that participants understood certain advantages of BYOD, but concern still remained. The benefits were very clear:
- Convenience of capturing data on devices that are already in patient’s daily lives
- Increasing compliance with reminders integrated with our other day-to-day notifications
- Reducing or eliminating special-purposed device costs.
The most prominent concerns included the availability of smartphones and their ease of use. In addition, it is important to consider developing identical experiences on iOS and Android systems, preventing study sample bias, and ensuring proper security measures are thought out. Although we are rapidly approaching two billion smartphone users worldwide, certain segments of the population, such as the elderly, may not have access to a smartphone or know how to use one. This could also lead to study samples biased in age, global region, and socio-economic status. One way to avoid this might be to implement a hybrid approach where trial-eligible patients who own smartphones complete their assessments using the BYOD app on their own device, and those patients who don’t own one are provided a dedicated device. This would require studies to provide devices, but fortunately, there are many widely available and inexpensive options, like the iPod Touch, which can be given to trial participants. Although this may solve the problem of the devices themselves, the question of ease of use still remains. Mobile apps for trials then becomes the solution. If designed well, apps can be easier to use than even the simplest paper method and the small screen size will not matter.
BYOD also introduces the concept of “mixed modalities” into the trial, meaning that different patients will use different devices (some will use handhelds, others using tablets or computers). It is likely that different modes of administration will have different screen sizes, which may influence how patients interface with them. These questions are not slowing down the adoption of BYOD, in fact quite the opposite is happening. Initial data suggests there are minimal to no differences in how patients answer assessments using different MOAs.
Current Trends and Moving Forward
BYOD in clinical trials isn’t a concept of the future. Studies using patient BYOD have already been completed and many are currently underway.
In a vaccine surveillance study, the BYOD approach not only offered patients the flexibility of their preferred device but also assisted with electronic data capture. In addition, 85% of participants opted to use their own mobile device or personal computer, vastly reducing provisioning requirements for the study. Given the large scale and geographic spread of the study, 100% provisioning would have been costly, both in terms of purchase of devices, as well as the associated logistics, maintenance, and support necessary. Considering that the average provisioning cost per device (including setup, monthly data charge, and monthly lease) was around $400, the savings are clear to see.
With 85% of participants using their own device (PC, laptop, mobile), the BYOD enabled a data capture method that would have previously not been possible. Participants benefitted from a user-friendly interface and being able to contribute from the familiarity of their own device. They were also able to easily complete assessments and report outcomes throughout the study in the simplest possible way.
In another more recent trial studying the effects of melatonin on migraines in adolescents, the use of the BYOD method allowed for more accurate data collection and easier participation for patients. The BRAiN-M Study consisted of adolescents ages 12-17. They would enroll online and come in for a two hour in-person study visit. Melatonin or a placebo medication was then mailed to the participant’s home. A daily “headache diary” was completed online or through a smartphone, with medication following after. Fitbit devices were worn at night to track sleep patterns. In addition to understanding how to prevent teenage migraines, lead investigator, Dr. Amy Gelfand of UCSF, was looking to make pediatric migraine clinical trials more inclusive and accessible
Often, participation in conventional pediatric migraine clinical trials is too difficult for families to orchestrate. Most require many in-person visits, which results in missed school for the kids and missed work for their parents. A pediatric migraine study conducted in 2013 found that 44% who declined to participate in the study cited either “distance too far” or “did not have time to participate” as their reason for declining. By utilizing technology, the BRAiN-M study was able to remove these barriers to participation.
The true impact of BYOD can be seen in late phase clinical trials. Unlike the small populations that are closely managed in pre-approval clinical research, late phase studies require management of large, diverse populations by physicians and health care professionals over long periods to time with fewer “touchpoints.” As a result, providing patients with hardware for electronic data capture has historically been costly. A BYOD approach offers an extremely cost-effective strategy to engage patients through sharing information and capturing data on their devices. The requirement to provide devices is significantly reduced, or even removed altogether.
By reducing the cost of full-scale provisioning and significantly reducing the logistical challenge of managing and maintaining large quantities of devices across the globe, a device independent approach delivers an extremely cost effective patient-centric strategy for sponsors and CROs that both enhances patient engagement and addresses data capture requirements.
Parallel 6 has developed the Clinical 6™ platform, an end-to-end patient centric engagement platform for the healthcare and life sciences industries. Clinical 6™ enables clinical trial stakeholders to digitally recruit, eQualify, eConsent, and engage clinical trial participants. If you would like to learn more about Parallel 6 and Clinical 6™, please visit our website and request a demo.