While the life sciences industry has been historically cautious to adopt technology trends, the COVID-19 pandemic forced an immediate transformation and modernization of clinical trial processes. When the COVID-19 pandemic forced the operational disruption of clinical trial sites and hospitals, sponsors realized the need for more agile tools to help capture patient data in a remote capacity. Regulators across the globe released guidance for the continuation of clinical trials amidst these new hurdles.
In March of 2020, the US Food and Drug Administration (FDA) expressed strong (eCOAs) and encouraged sponsors to provide devices to patients lacking access. The European Medicines Agency (EMA) took an even more direct stance, suggesting that devices to record this information, ushering in adoption of the bring your own device (BYOD) model. Today, BYOD has become an essential cornerstone of modern clinical trials.
The adoption of BYOD
Eager to resume clinical trials while also complying with COVID-19 safety measures, the life sciences industry accelerated their adoption of new methods for collecting patient data, with BYOD at the forefront of that effort. Using personal technology such as mobile phones, tablets and wearables in a clinical setting presents unique opportunities for improving patient engagement, while also cutting costs.
These digital assessments simplify the tracking of patient progress outside the confines of the site environment, allowing sponsors to collect data and support the safety and efficacy of a treatment and its impact on patients’ quality of life. Enabling patients to use their own devices also eliminates the time and cost of commissioning devices for every patient, which can drastically reduce a trial budget while accelerating study start-up.
Beyond the budgetary benefits, the BYOD option has also been proven to increase compliance. Giving patients the option to complete tasks on a device they are familiar with lessens patient burden and ultimately yields better engagement.
Electronic patient reported outcomes make it easy for patients to input their health data, and to use alerts, reminders and other embedded tools to weave the trial into their daily lives. This allows sponsors to keep patients engaged while incorporating their personal feedback into the research environment.
The adoption of virtual models encourages sponsors to think about how patients interact with trials, how much time they really need to spend at on-site appointments, and what technology and services can be leveraged to enhance the experience while capturing a consistent stream of quality data. BYOD benefits patients by giving them the option to download study apps directly to their devices without the hassle of lugging around an extra piece of technology just to record their health data. A found that 94% of participants would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Through this capability, patients are able to use the device they are familiar with to access their own health data, alerts and calendar data. As a result, BYOD effectively eliminates barriers to participation while simultaneously enhancing the overall engagement experience of each individual patient.
Data security considerations
While the benefits of BYOD are undeniable, sponsors still have an obligation to address concerns surrounding data security, app performance and regulatory compliance. This includes adhering to the EU’s General Data Protection Regulation (GDPR) for “Minimal data collection” where required. Working with technology partners who understand the demands of the clinical regulatory environment is invaluable in ensuring eCOAs and other digital tools follow all regulations and can prove compliance. Taking the time to strategically plan and implement new technologies will mitigate these concerns and make for a hassle-free BYOD trial experience.
Across organizational functions, we are keenly aware today that the pandemic has been instrumental in inciting digital transformation. In the area of clinical research, it has become undeniable that, through BYOD, everyone can win in the decentralized trial environment. BYOD provides a safe, accessible, convenient and cost-effective way to collect endpoint data for regulatory submissions. Patients enjoy the ease and comfort of using their own devices, sponsors achieve time and cost savings, and regulators experience increased compliance. As remote capabilities take their place as the new standard across all industries, BYOD will continue to gain momentum and facilitate a more streamlined and high-quality clinical trial experience for patients and sponsors alike.