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Bring-Your-Own-Device In Clinical Trials: Achieving High Quality Data At Lower Cost



Contributed Commentary By Paul W. Glimcher

February 21, 2019 | A decade ago most big corporations were concerned about security and, as a result, issued Blackberries to employees solely for use at work. But as technology improved, companies like IBM and UPS and even the U.S. Department of Defense have let employees and soldiers in the field use their own smartphones. Surveys now suggest that half of all companies in North America allow bring-your-own-device (BYOD), recognizing the security capabilities of current smart devices as well as the reduced costs, higher performance, compliance rates and ease of managing a single phone.

An exception to this global trend is the pharmaceutical industry, which has been hesitant to adopt BYOD for collecting personal health data in clinical trials. Today, BYOD is used in less than 10% of clinical studies, despite strong evidence this is precisely the situation where it would be most effective to control costs, improve compliance and enhance data integrity.

As a result, the industry is missing out on a strategy that would ultimately benefit consumers and pharmaceutical companies by accelerating the development of new drugs.

Why are pharmaceutical firms reluctant to introduce BYOD? There are probably many reasons. Pharma is conservative by nature. Data quality is a primary goal and managers know that the processes they have used for years yield sufficient results. Security is also important, and fears (often unfounded) about smartphones abound. Moreover, there are very few cutting edge tech firms with deep enough clinical experience to produce what Big Pharma requires in trials.

Rather than letting patients enter their health outcomes data on personal devices, these firms are likely to still rely on paper forms and surveys, simple web questionnaires and phone interviews, or to provision smartphone-like devices to study subjects.

Yet evidence suggests that BYOD has clear advantages over provisioning by almost every measure. The rate of survey and diary compliance with BYOD ranges between 87% and 96% compared to 60% to 80% with a provisioned device, a difference that reflects the high levels of contact consumers have with their own phones throughout the day. In addition, the shipping and configuration changes associated with provisioning more than double the cost of the actual device. With BYOD, the user-friendly app is simply uploaded to the subjects’ phone and then automatically deactivated when the study is concluded.

Another advantage of BYOD is the ability to gather data on a real-time basis, instead of when the subject is holding the provisioned device (studies suggest this might be less than once daily). Real world evidence, a current focus of the Federal Drug Administration, is also easy to gather in the BYOD environment and lets researchers focus on subjects’ activity levels, location, environmental exposures, nutrition, and social-behavior patterns.

This additional data has recently been the subject of a number of FDA proposals, which suggests it can bolster the scope and accuracy of a clinical study. In a diabetes trial, for instance, subjects keeping nutritional diaries can use their personal device to enter in 60 seconds what they are eating when they are eating, rather than waiting until the end of the day to use complicated forms or web interfaces, which are slower. A personal device can often be programmed to detect when meals are taking place so researchers can provide automated reminders that further enhance compliance and accuracy.

For reasons like these, most med-tech companies today believe that BYOD is inevitable. If so, what are the perceived risks and remaining roadblocks holding back wider adoption?

Smartphones are nearly ubiquitous in industrialized countries and all ownership trends will continue in this direction, with more than 70% of people in industrialized countries holding cell phones. For those who do not, the vast majority are young children or the very poor, and contrary to popular belief the elderly are already well equipped in this regard. As a result, there should be no concerns about designing a partially, or even completely BYOD trial, as data transmission rates are low and network connectivity is pervasive.

With modern operating systems largely limited to iOS and Android, the ecosystems built around them have become increasingly robust, reliable and secureas well as compatible. To overcome device fragmentation, modern apps are designed to account for all variations in the size, connection, and capacity of available phones. If not, customers’ everyday transactions such as banking or calling an Uber would not function properly. In a similar way, the apps downloaded to personal devices in a clinical trial are now able to accommodate any phone size or system and to operate in a fully-secure manner. If a participant is willing to type their social security number, date of birth, and credit card details into a banking app, why would Pharma doubt that a smartphone could safely transmit blood glucose levels?

The widely-held belief that apps are prone to break down and require frequent technical assistance is no longer valid for commercial grade products of the type Pharma should demand. Today, professional software developers create apps that are thoroughly tested for quality assurance and data privacy before being released. Moreover, the best apps effectively diagnose their own problems, sending data back to the home base so engineers can fix glitches remotely. Subjects in a clinical trial who might not be tech savvy need not have any direct involvement or interactions with a call center or help line.

Looking ahead, the ultimate goal is to create a seamless, user-friendly BYOD model for the pharmaceutical industry that increases patient retention and compliance, and efficiently collects and transmits data while reducing the cost burden.

As momentum grows across many industrial sectors to integrate BYOD into mainstream corporate practices, the pharmaceutical industry should not be left behind. Advances in technology and connectivity as well as data privacy, coupled with widespread smartphone ownership, are likely to spur further integration of BYOD as an essential tool in clinical trials. The BYOD revolution promises better data, higher compliance, and lower costs. What’s not to like?

Paul W. Glimcher is CEO of Datacubed Health, a pioneering healthcare technology company that collects accurate real-world data, eCOA, ePRO and novel data solutions tailored to everything from remote patient engagement to virtual clinical trials. Glimcher also holds the Julius Silver, Rosyln S. Silver and Enid Silver Winslow Chair of Neural Science at New York University (NYU) and is Professor of Neuroscience and Physiology at NYU’s Langone School of Medicine. He is also Professor of Economics and Psychology at NYU. By tapping into what makes humans human, Datacubed Health is changing how healthcare approaches big data to create a healthier world. Glimcher can be reached at paul.glimcher@nyu.edu.

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