Advances in digital technology have opened new avenues for remote research studies that enable data collection from patients' homes. As a result, most companies have employed some form of electronic patient-reported outcomes, or ePRO, in clinical trials.¹ Increasingly, ePRO involves patient and/or site staff using their own devices to enter data — commonly called "BYOD" (Bring Your Own Device).

For study teams, the primary benefit of BYOD is a significant reduction in cost and logistical burden compared to provisioning devices, providing training and supporting patients on their use. And, trial patients get to use the devices they are most familiar with. This, in turn, improves compliance, which is a benefit to all.²

Here we review how BYOD is used today, where it's headed and how sponsors can prepare to implement this approach to save significant time and costs in their upcoming clinical trials.

BYOD Today

BYOD is used regularly in the post-approval research space and is now spreading into pre-approval research. Although at this writing there have been no label claims supported by primary endpoint data collected using BYOD, this will change shortly; the first regulatory submissions are taking place this year. 

It's important to note the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both support remote patient research and the use of electronic tools to collect patient data. In fact, the 21st Century Cures Act, enacted in the US in 2016, promotes the use of patient experience data in clinical decision-making.

Where we’re Heading:  BYOD 2.0

Two simultaneous technology advances are accelerating remote research and expanding the definition of BYOD: conversational interfaces and wearable sensors. Such 'BYOD 2.0' devices are being used in Phase III trials to collect exploratory endpoints, and we expect them to soon be accepted as valid instruments for collecting primary and secondary endpoints.

Conversational Interfaces

Conversational interfaces are expected to become our most common form of interaction with technology in the very near future. Comscore predicts that by 2020, half of all online searches will be voice activated.³ It’s not hard to imagine how voice assistants like Amazon Echo or Google Home may be put to use in remote research. Imagine a voice assistant announcing “It’s time to record your blood pressure.” Thus prompted, the patient would use a blood pressure monitor and then read out results to the voice assistant, which would automatically transmit the results to the trial’s electronic data capture (EDC) system (figure 1).

Wearables and External Devices

Wearable devices and sensors such as activity monitors, pulse oximeters, and heart-rate monitors are possible sources of clinical trial data, and in many cases, may be more robust than other performance measures. And, objective readouts from these devices can be synched with electronic patient diaries to give a broad picture of the patient’s life — and to understand the link between the wearable data and more subjective measures that patients report via diaries.

BYOD 2.0 technology makes data reporting much more accessible for patients. There are limited dexterity or vision requirements, so it broadens the eligible patient populations. Those who might otherwise be excluded due to visual or motor impairments can still take part.

Recommendations

Admittedly, BYOD is not appropriate for all studies, but sponsors who want to take advantage of the significant cost and time savings it offers can get started with these quick tips:

• Discuss ideas with regulators. Both the FDA and the EMA are willing (and eager) to have early conversations with sponsors about what will be acceptable.
• Consult the work of the ePRO Consortium, which has published a framework for selecting and evaluating non-medical grade wearable devices to support labeling claims.
• As needed, enlist the help of an outside firm to evaluate new BYOD technology in a clinical setting.
• Conduct a small, BYOD sub-study in parallel with the main study as a way to pilot it.

Conclusion

BYOD has been a popular discussion topic for the past five years, and interest in it is clearly growing. Initial concerns about technical, operational, security and regulatory issues have been addressed and need not prevent its adoption. In fact, there is much published research to confirm the validity of employing a BYOD strategy to demonstrate the equivalence of outcomes from patients' own devices compared to paper diaries and provisioned devices.

As technology continues to advance and BYOD expands into pre-approval research, clinical trial sponsors adopting this approach will realize significant cost and time savings, which ultimately leads to more effective clinical research.

References

¹ Lamberti, Mary Jo, Moskowitz, Jesse, and Getz, Ken, “Tufts CSDD Study of ePRO Usage in Clinical Trials,” June 2014.
² Ibid
³ Olson, Christi, “Just Say It: The Future of Search Is Voice and Personal Assistants,” Campaign, April 25, 2016.