Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims

Abstract

Bring-your-own-device (BYOD) methods for collecting patient-reported outcome (PRO) data in clinical trials can decrease patient burden and improve data quality. However, adoption of BYOD in clinical trials is limited by the absence of publicly available case studies where BYOD PRO data supported regulatory medical product approvals. Anecdotally, we are aware of multiple examples where efficacy and safety label claims were based on BYOD PRO data; however—except for one—these examples have not been made public. The absence of these case studies can lead sponsors to be hesitant to use BYOD for capturing primary and secondary PRO-based endpoints in their trials. This commentary outlines the context of the issue faced and concludes with a call for sponsor transparency with regard to BYOD use through publicizing where approved labeling claims were based on BYOD data. We suggest how this data could be systematically captured going forward. Sharing this information will benefit the clinical trials enterprise by increasing confidence in the utilization of BYOD and provide opportunities to enhance patient-centricity.

Mobile health technologies in an interventional hybrid study on actinic keratosis: Results from an early phase randomized controlled trial investigating the safety and efficacy of a cytosolic phospholipase A2 inhibitor gel in photodamaged skin

“…Supplemented by questionnaires on patient-reported side effects, we were able to ensure patient safety using remote assessments which supports the BYOD concept in contemporary clinical research. 34,47 Hybrid trials that incorporate the use of PSPs do recognize and report on the fluctuations in image quality, 48 which can be ameliorated by image quality assessment by dermatologists, as performed in our study, or by the integration of convolutional neural networks for image quality assessment. 49 Despite the many advantages of collecting PSPs, changes in ambient…”

“…24,[30][31][32] The implementation of decentralized aspects in the trial design permits a more dynamic data collection and can readily be achieved in dermatological trials by making use of smartphones. 33 By incorporating the concept of 'bring your own device' (BYOD), 34 patients' smartphones can be used to collect patient-reported outcome measures as well as patient-obtained smartphone photographs (PSPs) for store-andforward remote assessments. 35,36 Due to an above average smartphone penetration of >90% and high number of clinical trials per capita, Northern Europe is well-suited to early adoption of BYOD to decentralize clinical research.…”

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

“…This shift also brings up the question about the compensation of research participants’ time and direct costs of the technology use since they are taking over some of the tasks of the research team 29. To mitigate acceptance issues and increase participants’ buy-in, patient groups should be involved in the selection of patient-centred technologies whenever possible to enhance the success of DCTs 30 31. When possible, DCTs should be integrated as a part of patients’ follow-up with the support of their caregivers (health professionals) in the routine health facilities/hospitals.…”

Bringing decentralised clinical trial protocols to life

“…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.…”