Choice Matters: BYOD ePRO and the Patient-Centric Approach

Bring your own device (BYOD) has been a recognized ePRO approach for the past decade and arguably for as many as 20 years. Despite the widespread ownership of advanced smartphones and tablets, the industry has been slow to embrace BYOD as a mainstream approach. However, as the push for greater patient-centricity in clinical trials gains momentum, the industry is finally recognizing that allowing patients to use their own devices can improve their trial experience without compromising data quality.

Making clinical trials part of daily life

BYOD ePRO allows patients to use their laptops, tablets, or smartphones to complete trial activities. This helps integrate ePRO into patients’ daily routines through a device they are already familiar with and travels with them wherever they go — no need to carry around two separate devices or worry about keeping them both charged. This is particularly important when capturing spontaneous events like headaches or stomach pains that are not captured at set times during the day.

In the past, when data plans were expensive, it was less certain that patients would be willing to use their own devices. However, this concern is outdated as data plans have become more affordable, and Wi-Fi connectivity is widespread. Study designs rarely result in significant data usage, so minor allowances can offset any costs associated with completing ePRO assessments.

While not every patient may choose BYOD participation, the benefits are unmistakable for those who do. Using their own device gives patients more control with a familiar and personalized experience. For example, they can customize notifications and interaction preferences, making their participation in the clinical trial feel more like a typical consumer experience.

Challenging BYOD misconceptions

One of the most significant barriers to BYOD adoption is whether regulators will accept data. The recent guidance from the FDA and EMA on the use of BYOD is very welcome as it will help reduce the perceived risk. However, regulators have always been open to BYOD as long as the data captured stands up to the usual rigors of data collection —secure, reproducible, accurate, audit trails, etc. Regulators want to understand what checks have been put in place to confirm that data sets are consistent even when collected through different devices and screen sizes.

Studies demonstrating the equivalence of data collected through BYOD and provisioned devices are not new. In a study of chronic obstructive pulmonary disease (COPD) patients, Hudgens et al. concluded that assessment completion was high and scores were equivalent between the provisioned and BYOD devices in the diverse patient population.¹ Byrom et al. also concluded that there is strong evidence of instrument measurement equivalence for BYOD use across the most widely used response scale types.² One of the most significant leaps forward is the reassurance that clinical trials have also now used BYOD data as primary or secondary endpoints to support regulatory approval, most notably for COVID-19 vaccines.

The question remains: will this be enough?

The idea of patients using their own devices for ePRO has been challenging for the industry to embrace. The slow adoption of BYOD in ePRO and eCOA can be traced back to the historical development of these systems. Unlike EDC, which transitioned directly from paper to electronic systems, eCOA initially moved from paper to provisioned personal digital assistant (PDA) devices. These devices were standardized across studies with known screen sizes, which could be considered ‘conditional formatting.’

The next step is to enable use on any device with a minimum screen size requirement to ensure reproducibility, accuracy, and validity. The historical stepping stone (provisioned PDA devices) has ingrained the belief that electronic patient data capture requires a specific device to ensure comparable data sets. This preconceived notion has held the industry back and is preventing the natural progression to incorporating BYOD as an option in every study.

Think holistically about your BYOD strategy

Beyond the scope of eCOA, the industry must consider the broader patient experience. Patients are expected to engage with a variety of digital technologies, including eConsent, telehealth visits, access to educational content, training, and even the delivery of medications to patients’ homes.

This leads to a risk of ‘app overload’ where using multiple, disconnected apps reduces efficiency and engagement. In the business world, using different apps for messaging, video, phone, and whiteboard ideas is already being shown to slow down collaboration and productivity.³

To address this issue, a holistic approach is necessary. This involves providing all necessary tools and information within a single app and carefully considering what should be digitized and what can remain in traditional, in-person formats.

While historical views and practices have slowed the adoption of BYOD, it is imperative for the industry to embrace this patient-centric approach fully. The adoption of BYOD ePRO in clinical trials significantly benefits patients, sites, and sponsors. A flexible approach, where patients can choose to use their own device if suitable, offers enhanced convenience, control, and familiarity. This reduces provisioning pressures on sites and ultimately leads to higher engagement and compliance.

As clinical trials continue to evolve in the digital age, including the use of personal devices is not just a convenience; it’s a fundamental step toward improving the patient experience and ensuring the success of modern clinical research.

Learn more about Veeva eCOA.

References

<sup>1. Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings
2. Measurement Equivalence of Patient-Reported Outcome Measure Response Scale Types Collected Using Bring Your Own Device Compared to Paper and a Provisioned Device: Results of a Randomized Equivalence Trial
3. Businesses must end hybrid working app overload</sup>