BYOD 2.0: A More Inclusive Approach to eCOA in Clinical Trials

Chris Watson, PhD | |

Advances in digital technology have opened new avenues for remote research studies, i.e., those that enable data collection from the patient’s own environment. As a result, most companies have employed some form of electronic patient-reported outcomes, or ePRO, in various trials.1 The “e” part of ePRO can indicate devices that are provisioned by the sponsor, or patients using their own connected devices—commonly called “BYOD” (Bring Your Own Device) ─ which includes mobile phones, tablets and computers.

Observations on the Uptake of BYOD

For study teams, the primary benefit of BYOD is a perceived, significant reduction in cost and logistical burden compared to provisioning devices. For patients, the main benefit is the ability to participate in trials using the devices that they are most familiar with. This, in turn, improves compliance, which is a benefit to all.[i]

 

Regulators support electronic tools for collecting patient data

 

BYOD is used regularly in the post-approval space and is now slowly filtering into pre-approval research. Although there have been no label claims supported by primary endpoint data collected using patients’ own devices to date, we anticipate that this will change shortly.

Typically, resistance to BYOD stems from technical, operational, security and regulatory concerns. But, since these concerns can—and have been—addressed, they need not prevent adoption. In fact, there is much published research to confirm the validity of BYOD in demonstrating the equivalence of outcomes from patients’ own devices compared to paper diaries and provisioned devices.

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.

Expanding Patient Populations

Current data capture technologies (whether provisioned or BYOD) can exclude valid patient populations from participating in clinical trials—those with physical limitations that make self-reporting difficult. Examples include some elderly populations and those with vision problems, neuropathy, and motor dysfunction, such as patients with glaucoma, Parkinson ’s disease, or arthritis.

However, the latest technologies can overcome some of these limitations and expand the use of ePRO to some populations that have been excluded up until now.

 

Learn how sites are using BYOD technology to improve patient compliance. LISTEN TO THE FULL EPISODE HERE.

 

Introducing BYOD 2.0

Given the pace of change in technology, we foresee that many researchers who adopt BYOD will go straight to “BYOD 2.0,” which captures data from new technologies, like voice-activated assistants, chatbots and wearable/external devices.

Such BYOD 2.0 devices are being used in patient support programs and are starting to be used in Phase III trials to collect exploratory endpoints. Eventually, we expect that these tools will be accepted as valid instruments for collecting primary and secondary endpoints.

Conversational Interfaces

Conversational interfaces are expected to become the most common form of our interaction with technology; Comscore predicts that by 2020, half of all online searches will be voice-activated.[ii] Smart speakers, such as Echo from Amazon, can be viewed as advanced forms of Interactive Voice Response (IVR) systems and are tapping the power of artificial intelligence, voice recognition, natural language processing, and speech synthesis to build out conversations.

It’s not hard to imagine how voice assistants may be put to use in remote research. A voice assistant that’s been interacting with a patient all day could, at the appointed time, announce “It’s time to record your blood pressure.” Thus prompted, the patient would take his or her blood pressure using a monitor and read out the results to the voice assistant. The program would then automatically transmit the results to the trial’s electronic data capture (EDC) system.

“Both wearable and external devices may prove to be more objective and robust than other performance measures”

Wearables and External Devices

Wearable devices and sensors, including activity monitors, pulse oximeters and  heart-rate monitors, as well as external devices – those that are physically separate from the user, including movement detection cameras, weighing scales, and digital spirometers ─ are possible sources of clinical trial or post-approval data, and may prove to be more objective and robust than other performance measures. For example, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is exploring activity monitors for evaluating impairment in patients with Parkinson’s Disease (rather than the standard six-minute-walk distance test) 3. The hypothesis is that an activity monitor will give a clearer and more objective view of a patient’s gait than an investigator’s observation.

BYOD 2.0 technology makes data reporting much more accessible for patients, and it’s a very natural process that fits seamlessly into a patient’s day. Objective readouts from BYOD 2.0 devices can also be synched with electronic patient diaries to give a broad picture of the patient’s life and to understand the link between the BYOD 2.0 data and more subjective measures that patients report via diaries.

Capture more objective data through BYOD wearable and external devices.

 

Chris Watson, PhD is the Director of Product Strategy, Digital Patient at ERT.

 

References

  1. Lamberti, Mary Jo, Moskowitz, Jesse, and Getz, Ken, “Tufts CSDD Study of ePRO Usage in Clinical Trials,” June 2014.
  2. Olson, Christi, “Just say it: The future of search is voice and personal assistants,” Campaign, April 25, 2016.
  3. http://www.imi.europa.eu/sites/default/files/uploads/documents/About-IMI/research-agenda/IMI2_SRA_March2014.pdf
  1. Lamberti, Mary Jo, Moskowitz, Jesse, and Getz, Ken, “Tufts CSDD Study of ePRO Usage in Clinical Trials,” June 2014.
  2. Olson, Christi, “Just say it: The future of search is voice and personal assistants,” Campaign, April 25, 2016.
  3. http://www.imi.europa.eu/sites/default/files/uploads/documents/About-IMI/research-agenda/IMI2_SRA_March2014.pdf
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