Electronic Clinical Outcomes Assessments (eCOA) play a central role in decentralized clinical trials (DCTs). eCOAs allow patients to share data about their treatment experience, outcomes and quality of life, all from the comfort of their homes.

Once sponsors add eCOAs in DCTs and hybrid trials, a common question emerges: Can patients reliably complete eCOAs on their personal devices?

Giving patients the option to download study apps to their phones rather than providing them with an extra piece of study specific hardware brings benefits for patients, clinical site staff and sponsors. Bring your own device (BYOD) options are more convenient and familiar for users who don’t want to learn a new interface. Patients are also more likely to have their personal devices with them at all times, ensuring they receive alerts to complete assessments on time. It is one more way sponsors can improve compliance and reduce the burden of participation.

At the same time, sponsors benefit from lower costs and faster timelines when they don’t have to acquire, ship and manage provisioned devices. This can accelerate study startup while potentially trimming hundreds of thousands of dollars from a larger trial budget.

However, sponsors need to be thoughtful about how they plan and implement BYOD strategies within their trial. This begins by considering the regulators.

Approving BYOD

Federal regulators, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), have indicated an openness to BYOD strategies, but they have yet to provide specific guidance on its use. If sponsors plan to use data collected from personal devices as a primary endpoint or in a pivotal trial, they need to be sure regulators will approve this mode of data collection before moving ahead.

We encourage sponsors to consider BYOD as soon as they decide to use eCOA, and to meet with regulators as part of the planning process to make their case. Regulators will want to see evidence that an assessment can be completed across multiple device types, that the experience is consistent across devices, and that patient behavior or the use of personal technology won’t compromise data quality and security.

The same experience on every device

To make the case for BYOD, sponsors first need to demonstrate modal equivalency. That means that the eCOA will be experienced in an equivalent fashion on every screen size, device type and operating system supported by an eCOA Vendor’s BYOD solution – including paper if that is an option. This evidence can’t be anecdotal – e.g., “we showed it to 10 patients and they said it was fine.”

Regulators may want to see evidence of a ‘faithful migration,’ which indicates that the use of alternative modes of data collection will not lead to biases in patient response.

Many standardized instruments include standard response scales such as numerical rating or ordinal scales which have been preliminarily vetted across modes to show equivalency. However, sponsors still need to demonstrate that more substantial modifications introduced during migration doesn’t impact how the patient interprets and responds to the questions.

For example, if a user has to scroll down to read a complete question on one mode, but not another, evidence may need to be provided to show that the change didn’t impact the user experience and patient comprehension.

At IQVIA, as part of our eCOA due diligence process we accelerate this process by pre-vetting the eCOAs in our eCOA library to ensure that they adhere to faithful migration best practices.

However, if a sponsor wants to use an eCOA that hasn’t been previously migrated to an electronic format, sponsors may be advised to conduct cognitive debriefing, usability testing, or a full-blown qualitative equivalency study especially if the eCOA data is connected to a primary endpoint or if the assessment uses a non-standard response scale (i.e., a human body map). IQVIA has in-house scientific experts who can support executing these methodologies as these can add time to the trial implementation process, so planning ahead is critical to keeping the timeline on track.

Technology risks must be addressed

Once an eCOA has been proven to work equivalently across modes of administration, sponsors also need to consider any potential risks related to technological or human behavior.

Sites can’t control the specific features on patients’ personal devices or how they use them. That includes requiring them not to turn notifications off, leave their device in airplane mode or on Do Not Disturb, or downloading an app or extension that interferes with the eCOA in some way. They also cannot require users to complete system upgrades or notify them if they change their devices.

However, sites can implement strategies to mitigate risks related to these technical issues, without compromising patient privacy. These may include:

• Verifying that a patient’s device has the necessary operating system and upgrades to support the eCOA Vendor’s BYOD solution as part of the onboarding process.
• Training patients on the importance of responding to alerts and system upgrade notifications.
• Providing patients with access to a trial concierge or helpdesk to troubleshoot issues with the eCOA.
• Proactively following up with any patients who miss more than a set number of eCOA submissions to be sure their technology is working correctly.

Having a proactive plan in place to address technology-related compliance risks and giving patients a human contact to troubleshoot challenges will demonstrate to regulators that you have thought through your BYOD risks and are ready to support patients when they have a need.

Because BYOD is a newer practice in clinical research, many sponsors are still unfamiliar with how to implement it and secure regulatory support. Working with a vendor who has experience validating eCOAs for BYOD trials can ensure they do proper due diligence before meeting with regulators.

To learn more about considerations that need to be made when implementing a BYOD strategy, watch this on-demand webinar today. You can also reach out to us at eCOA@iqvia.com to speak with an expert about your BYOD strategy.