TECHNOLOGY AND DATA MANAGEMENT T
he use of remote monitoring tools like sensors and trackers in decentralised clinical trials (DCTs) is showing no sign
of slowing down, but the onus is on wearable makers, as well as study sponsors, to ensure there is proper device validation. As reported in an exclusive analysis by Clinical Trials Arena, wearable sensors and tracking devices in DCTs averaged at 42 clinical trials per year between 2010 and 2014. But this has consistently increased since 2015, breaking the 200-study mark last year. The biggest jump was seen between 2020 and 2021, rising by 44 trials from the previous year. Remote monitoring that involves wearables which are designed to track trial participant outcomes between regular onsite visits, while also reducing overall visit numbers. In an advance in the DCT landscape,
long-established assessment tools such as electronic Clinical Outcome Assessments (eCOAs) are now supported by wearable sensors and tracking devices. Wearables enable a broader view of the patient journey as it complements and enhances electronic Patient Reported Outcome (ePRO) collections, adds Nico O’Kuinghttons, vice president of commercial, DCTs at Huma. The different digital solutions can allow for broader and better data collection, O’Kuinghttons explains. Algorithms allow for information collection that can then complement and enable a fuller assessment of surrogate endpoints.
Diseases with most clinical trial remote monitoring
In terms of the respective therapeutic spaces employing wearable sensors and tracking devices, the analysis reported they are most used in central nervous system (CNS), metabolic space, and respiratory disorder trials. CNS has always been a frontrunner and innovator with sensors because many trial endpoints have been activity-based which sensors capture well, says John Reites, CEO of Thread, a DCT service provider. According to the GlobalData Clinical Trials database, there are 56 ongoing clinical trials employing sensors
There is also heightened interest in rare illnesses such as muscular degenerative
58 | Outsourcing in Clinical Trials Handbook
see many more options in terms of how these wearables can generate quality data in a study”
diseases where walking, eating, and movement matters, as well as dermatology where sleep and scratching patterns can be detected by sensors, Reites notes. Oncology is also a space with a growing interest in sensors to capture movement between visits, to indicate a treatment that allows a person to become less sedentary.
The future of sensors includes new forms of clinical trial endpoints such as electronic Device Reported Outcomes (eDROs), Reites options in terms of how these wearables can generate quality data in a clinical study, providing comfort to physicians, patients, and regulators, he adds. Some examples of the next-generation sensor endpoints include voice data capture for voice and tonality, aspects that cannot be captured in a traditional eCOA, he notes.
Wearable, sensor data validation necessary Considering the wearable and sensor explosion, O’Kuinghttons says that key questions tech makers need to consider include: What is the validation process of data generated? What’s the validation threshold that the study could recognise? What data is as A wearable for a study must be able to demonstrate to the regulatory entities that the data will be reliable to validate endpoints. There is regulatory guidance, particularly from the US Food and Drug Administration, on validation for wearables and sensors but it is broad, O’Kuinghttons says. Rather, wearable makers and sponsors are encouraged to come to the agency for further guidance. The onus is on both the wearable maker, as
well as the trial sponsor, to invest in research demonstrating validation, O’Kuinghttons adds. In terms of the evidence threshold for high-quality data, a recent article posited that
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