Considerations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies

Abstract

<b><i>Background:</i></b> Digital health technologies are attracting attention as novel tools for data collection in clinical research. They present alternative methods compared to in-clinic data collection, which often yields snapshots of the participants’ physiology, behavior, and function that may be prone to biases and artifacts, e.g., white coat hypertension, and not representative of the data in free-living conditions. Modern digital health technologies equipped with multi-modal sensors combine different data streams to derive comprehensive endpoints that are important to study participants and are clinically meaningful. Used for data collection in clinical trials, they can be deployed as provisioned products where technology is given at study start or in a bring your own “device” (BYOD) manner where participants use their technologies to generate study data. <b><i>Summary:</i></b> The BYOD option has the potential to be more user-friendly, allowing participants to use technologies that they are familiar with, ensuring better participant compliance, and potentially reducing the bias that comes with introducing new technologies. However, this approach presents different technical, operational, regulatory, and ethical challenges to study teams. For example, BYOD data can be more heterogeneous, and recruiting historically underrepresented populations with limited access to technology and the internet can be challenging. Despite the rapid increase in digital health technologies for clinical and healthcare research, BYOD use in clinical trials is limited, and regulatory guidance is still evolving. <b><i>Key Messages:</i></b> We offer considerations for academic researchers, drug developers, and patient advocacy organizations on the design and deployment of BYOD models in clinical research. These considerations address: (1) early identification and engagement with internal and external stakeholders; (2) study design including informed consent and recruitment strategies; (3) outcome, endpoint, and technology selection; (4) data management including compliance and data monitoring; (5) statistical considerations to meet regulatory requirements. We believe that this article acts as a primer, providing insights into study design and operational requirements to ensure the successful implementation of BYOD clinical studies.

Time-varying model of engagement with digital self reporting: Evidence from smoking cessation longitudinal studies

“…In fact, recent research demonstrated greater engagement with “bring-your-own device” clinical research as opposed to study-provided devices. Bring-your-own-device method potentially increase engagement because they tend to be more user-friendly and allow participants to use technologies that they are familiar with ( 41 , 42 ). Future research should examine whether our results generalize to this setting as well.…”

Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective

“…DiME also hosts a library of digital endpoints used by registrational clinical trials [ 28 ]. A recent work was published to discuss the “bring your own device” (BYOD) option as a more user-friendly strategy to allow patients to use familiar technologies, which can ensure better compliance and unbiased measurements [ 29 ]. This is closely related to and applicable for a DCT.…”

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“…From a regulatory perspective, the risk-benefit for provisioned device versus BYOD is complex and requires careful consideration. 26,27 Wearable or connected device Wearable or connected devices include static or wearable devices that can support remote data collection directly from the participant (e.g. wearables like actigraphs that monitor activity levels) or their environment (e.g.…”