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BYOD: the future of clinical trials

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While the life science industry has always been cautious about embracing technology trends, the COVID-19 pandemic has forced an immediate transformation and modernization of clinical trial processes. When the COVID-19 pandemic forced the operational shutdown of clinical trial sites and hospitals, sponsors realized the need for more agile tools to help capture patient data remotely. Regulators around the world have issued guidelines for continuing clinical trials amid these new hurdles.

In March 2020, the United States Food and Drug Administration (FDA) expressed strong (eCOA) and encouraged sponsors to provide devices to patients who did not have access to them. The European Medicines Agency (EMA) has taken an even more direct position, suggesting that devices to record this information, ushering in the 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 adhering to COVID-19 safety measures, life sciences the industry has accelerated its adoption of new methods of collecting patient data, with BYOD being at the forefront of this effort. The use of personal technologies such as cell phones, tablets and wearable devices in a clinical environment presents unique opportunities to improve patient engagement, while reducing costs.

These digital assessments make it easier to track patient progress outside the confines of the site environment, allowing sponsors to collect data and support the safety and effectiveness of a treatment and its impact on patients’ quality of life. patients. Allowing patients to use their own devices also eliminates the time and cost of commissioning devices for each patient, which can significantly reduce a trial’s budget while accelerating study start-up.

Benefits of compliance

Beyond the budget benefits, the BYOD option has also been proven to increase compliance. Giving patients the ability to perform tasks on a device they are familiar with reduces patient load and ultimately improves engagement.

Electronic patient-reported results allow patients to easily enter their health data and use built-in alerts, reminders and other tools to integrate the trial into their daily lives. This allows sponsors to maintain patient engagement while incorporating their personal feedback into the research environment.

Benefits for patients

Adopting virtual models encourages sponsors to think about how patients interact with trials, how much time they actually need to spend in on-site appointments, and what technology and services can be leveraged to improve patient experience. experience while capturing a steady stream of quality data. . BYOD benefits patients by giving them the ability to download study apps directly to their devices without having to lug around extra technology just to record their health data. A found that 94% of participants would definitely or probably be willing to download an app to their own mobile device for an upcoming clinical trial. With this capability, patients can use the device they know to access their own health data, alerts, and calendar data. As a result, BYOD effectively removes barriers to participation while simultaneously improving each patient’s overall engagement experience.

Data Security Considerations

While the benefits of BYOD are undeniable, sponsors still have an obligation to address data concerns security, application performance and regulatory compliance. This includes complying with the EU General Data Protection Regulation (GDPR) for “minimum data collection” where applicable. Working with technology partners who understand the requirements of the clinical regulatory environment is invaluable in ensuring that eCOAs and other digital tools meet all regulations and can prove compliance. Taking the time to strategically plan and implement new technologies will alleviate these concerns and enable a hassle-free BYOD trial experience.

Looking forward

Across all organizational functions, we are acutely aware today that the pandemic has been instrumental in driving digital transformation. In the field of clinical research, it has become undeniable that thanks to BYOD, everyone can win in the environment of decentralized trials. BYOD provides a secure, accessible, convenient, and cost-effective way to collect endpoint data for regulatory submissions. Patients appreciate the ease and convenience of using their own devices, sponsors save time and money, and regulators benefit from increased compliance. As remote capabilities become the new normal across industries, BYOD will continue to gain momentum and facilitate a more streamlined, high-quality clinical trial experience for patients and sponsors.