To bring or not to bring: Exploring the future of the BYOD data collection
We review the real value of a bring your own device strategy in clinical trials
There is an ever-expanding focus from pharma and clinical trial experts on the experience of patients when participating in clinical trials. In line with this, we've seen eClinical developers continue to advocate for an even easier way for subjects to submit information during a clinical trial.
Traditionally, Electronic Clinical Outcome Ayssessments (eCOA) data has been captured through devices procured by sponsors. But the switch toward the Bring-Your-Own-Device (BYOD) strategy, which has been taking shape recently, makes it possible for data to be entered as easily on a sponsor owned device as well as a patient’s personal mobile device.
In a nutshell, what is BYOD?
The BYOD approach allows patients recruited for a study to report on treatment results via their personal gadgets (smartphones or tablets). This concept is likely to help CROs and pharmaceutical sponsors to reduce equipment, maintenance, telecommunications and logistics costs, while also increasing flexibility in data capture. However, while being quite a breakthrough in the field of data management, BYOD still remains a subject of disputes among researchers. Some researchers keep having misgivings and reservations about introducing BYOD, opting for non-BYOD methods which have been working reliably in the past. Here are some of the concerns and challenging points raised by those who are still reluctant to make a switch toward BYOD.
Regulatory compliance. One of the concerns some researches express is that BYOD, being only recently introduced, has yet to gain solid regulatory platform to back it up with. Reality proves, however, that regulators have been catching up as well. As per the Passed in 2016, the 21st Century Cures Act by the FDA endorses patient experience data for drugs and devices (Sec. 3001 and 3002). This includes data submitted from personal smartphones and tablets.
Data security is another pressing concern associated with patient data, which organizations of all sizes need to understand. Unquestionably, security topic needs to be a top priority, and staff at all levels has to be regularly trained on how to ensure that sensitive information (patient PHI, etc) is not compromised. Application provider must ensure adequate data security when operating with mobile devices owned by the patients themselves. To counter the concern, eClinical developers worldwide stick to the opinion that the data is just as secure, if not more so, when sent from the patient’s own device. A personal device is less likely to leave the user's side, unlike an additional device or a bundle of paper reviews, that may become an afterthought. But there's no denying that increasing the use of personal and third party devices in healthcare highlights a need for the implementation of more specific BYOD policies and information security technology.
Data loss. One more risk, that occurs for several reasons: when a mobile device gets lost or stolen, is subject to upgrades mid-study, data plan restrictions, turning off in-app diary reminders, etc. To address this challenge, a judicious step for researchers would be to ensure that patients without a proper device (or unwilling to use their own device), or those changing to a device that is unsuitable mid-way through a study, can continue to collect their data. The quick replacement is important to reduce missing data — as it is when replacing a lost or damaged provisioned device supplied to a patient in a non-BYOD study. Also, in the event of theft or loss mentioned above, a mobile device management (MDM) policies, for example, can include remote wipe capability, which could come in handy should a device get lost or stolen.
False-consensus effect. In its overview CenterWatch commented on the general excitement toward the trend. But it also cautions pharma to be realistic and take into account factors whether patients are ready for BYOD. There is a term in psychology called “false-consensus effect”, when people are inclined to overestimate their beliefs, values, opinions and preferences. This phenomenon also occurs in eCOA. While this concern might be more challenging for developers and industry participants to approach, there is no denial that BYOD models have great potential to increase patient satisfaction, improve their experience and compliance, for subject tend to prefer using their own devices when submitting trial data.
Future looking bright for BYOD
As the industry is keen on moving towards cost-efficient and patient-centric clinical trials, eClinical solutions which maximize subject’s experience through features like BYOD keep looking more appealing and valuable for sponsors. Flexible solutions and options for patient-driven data streams will always be in demand. BYOD for eCOA is an excellent option for certain studies that reduces time and costs, manage deliveries, and increases patient involvement and willingness to participate in a study. In addition, using own device means that patients do not need much time to be trained to use it during a trial.
Breakthrough as it is, the topic of BYOD still raises many questions among market participants. To that end, a consultation with a reliable provider of such solutions should be the first step for sponsors looking into upgrading their study processes.