The life sciences industry has historically been cautious about adopting technology trends. The COVID-19 pandemic has forced an immediate transformation and modernization of clinical trial processesWhen the COVID-19 pandemic disrupted clinical trial sites and hospital operations, sponsors recognized the need for more agile tools to help capture patient data in remote capacity. Regulators around the world have released guidance for continuing clinical trials amid these new hurdles.
In March 2020, the U.S. Food and Drug Administration (FDA) announced (eCOA) and encouraged sponsors to provide devices to inaccessible patients. The European Medicines Agency (EMA) has taken a more direct position, Use your device to record this information and drive adoption of the Bring Your Own Device (BYOD) model. Today, BYOD is an essential foundation for modern clinical trials.
Adoption of BYOD
We want to resume clinical trials while complying with COVID-19 safety measures and life sciences The industry has accelerated adoption of new methods for collecting patient data, and BYOD has been at the forefront of that effort. The use of personal technology such as mobile phones, tablets and wearables in the clinical setting presents a unique opportunity to improve patient engagement while reducing costs.
These digital assessments simplify patient progress tracking outside of the site environment and allow sponsors to collect data and support treatment safety and efficacy and impact on patient quality of life. will do so. Enabling patients to use their own devices also reduces the time and cost of commissioning devices for each patient, significantly reducing trial budgets and accelerating trial start-ups.
Benefits of compliance
The BYOD option has proven not only to be a budgetary advantage, but also to improve compliance. Giving patients the option to complete tasks on familiar devices reduces patient burden and ultimately leads to better engagement.
Electronic patient-reported results allow patients to easily enter their health data and use alerts, reminders and other built-in tools to integrate the exam into their daily lives. This allows sponsors to maintain patient interest while incorporating personal feedback into the research environment.
Employing a virtual model, sponsors can improve their experience while getting a consistent stream of high-quality data on how patients enter trials, how much time they actually need to spend on on-site appointments. You start thinking about the technologies and services you can leverage to help BYOD benefits patients by giving them the option to download research apps directly to their devices without the hassle of carrying additional technology just to record their health data.a We found that 94% of participants were definitely or probably willing to download the app onto their mobile devices for future clinical trials. This feature allows patients to access their health data, alerts and calendar data using familiar devices. As a result, BYOD effectively removes barriers to participation while improving the overall engagement experience for individual patients.
Data security considerations
While the benefits of BYOD are undeniable, sponsors have an obligation to address concerns surrounding data. Security, app performance and regulatory compliance. This includes compliance with the EU General Data Protection Regulation (GDPR) for “minimum data collection” where required. Working with a technology partner who understands the demands of the clinical regulatory environment is invaluable in ensuring that eCOAs and other digital tools comply with all regulations and prove compliance. Taking the time to strategically plan and implement new technologies can alleviate these concerns and provide a hassle-free BYOD trial experience.
I’m looking forward to
Across organizational functions today, we are acutely aware of how the pandemic has helped drive digital transformation. In clinical research, there is no denying that BYOD allows everyone to win in a decentralized clinical trial environment. BYOD provides a secure, accessible, convenient, and cost-effective way to collect endpoint data for regulatory submission. Patients find their devices easy and comfortable to use, sponsors save time and money, and regulators experience increased compliance. BYOD will continue to gain momentum as remote capabilities become the new norm across all industries, facilitating a more streamlined and high-quality clinical trial experience for both patients and sponsors.