Digital health technologies such as sensor-based wearables are maturing from being seen as a hallmark of “boutique” remote monitoring-equipped health services organizations or, alternatively, as the obsession of fitness enthusiasts. Now that they are becoming an increasingly frequent component of clinical trials, regulatory authorities such as the FDA and CMS in the U.S., the European Medicines Agency (EMA) in Europe, the National Institute for Health and Care Excellence (NICE) in the U.K., and a running list of national and regional health authorities around the world are updating their standards frameworks to give coverage to these data-gathering tools. In unison with the research ecosystem’s readiness for their adoption, pharma and medtech companies are looking to streamline their integration in clinical trials.
There is a shared sense among industry stakeholders that the value of wearables, sensor devices, and clinical trial apps is immense and that we are at the dawn of a new R&D era. Research by Kaiser Associates conducted in 2016 suggested that by 2025 up to 70 percent of clinical trials would incorporate some type of wearable sensor as a way to track primary or secondary endpoints, compared to less than three percent at the time of the research. More recently, as of March this year there were more than 550 wearables studies underway, according to Clinicaltrials.gov. This trend is likely to accelerate now, in large part catalyzed by the COVID-19 pandemic and the spotlight it has shone on hybrid and decentralized clinical trials (DCTs), which both depend on and provide an ideal testing environment for such devices. As a result, appetite for trial-compatible wearables is growing exponentially, driven by their unique capabilities to collect longitudinal, high-frequency sensor data at a level of granularity practically impossible in “analog” clinical research.
To discuss the implications of embedding these digital health technologies in clinical trials, Medullan held a workshop that brought together 30 industry experts to share their insights on the way forward. The discussion centered around three major themes: challenges with implementation, choosing the best technology, and implications of bring-your-own-device (BYOD). In this first of three blogs, we look at the top challenges for integrating wearables in clinical trials, which coalesce around the following concerns: ensuring data security and privacy, identifying optimal fit-for-purpose technologies, achieving data integration, and accounting for usability and human factors.
Let’s look at each of these in detail by way of providing the pharma, medical device, and contract research communities with leverageable insights.
Data security and privacy
“Data privacy is a key gating factor for the industry to have the confidence to dip their toes in the wearables water. It´s a big nonstarter conversation if companies don´t have a compliant platform to digest, hold, manage, and report on the data those wearables produce,” said of the top barrier for seamlessly integration Adriano Garcez, Medullan’s director of Digital Health Strategy & Implementation. He flagged some of the most common standards to which data processing platforms for trials using wearables must adhere: personally identifiable information (PII), Environmental Protection Agency (EPA), and International Standardization Organization (ISO) compliance, as well as HITRUST certification.
Meeting these requirements is a steep challenge for organizations that are only at the beginning of their wearables journey, not least because developing a fully compliant platform from scratch can take up to three years. To get around this hurdle, trial sponsors and CROs often choose to partner with data management entities that operate licensed platforms adapted and utilized in the context of clinical trials. “This is the path to ensuring data privacy that most companies are taking right now,” said Garcez.
Identifying the best fit-for-purpose technology
Selecting the best wearable for each therapeutic area and target intervention was identified as the second most pertinent challenge by our workshop participants. What is at stake here – considering the capabilities of sensor-based devices to monitor and collect data remotely, longitudinally, and passively – is determining the optimal device in terms of meaningful digital outcome measures.
To that point, one of the panelists emphasized the role and relevancy of digital endpoints, which are increasingly moving from exploratory to secondary to primary. The bona fide leader in consolidating evidence about these measures is the Digital Medicine Society (DiMe), which curates an open, industry-sponsored, crowdsourced Library of Digital Endpoints.
“I wouldn´t be surprised to see a label claim in the very near future, given there are so many studies that are in the pipeline using these digital measurement methods,” said Arnab Roy, DCT lead within the R&D Excellence practice at ZS Associates.
Integrating high-frequency sensor data with existing clinical systems is another “hoop to jump through” on the road to full-scale adoption of wearables in clinical trials. With heterogeneous common data models (CDMs), extended reality (XR), and extended data capture (EDC) instances in place across healthcare organizations and clinical trial sites, figuring out how the data streams generated by sensor devices and trial apps fit into existing architecture must be solved on a case-by-case basis. This adds complexity to already complex and often manual data processing workflows, so it is an area that is begging for expert input and standardization.
Usability and human factors
Rounding out the top four challenges for streamlining the use of wearable devices in clinical trials is the need to factor in usability and human factors. Finding the right device or technology depends not only on the parameters of the study, but also on the device’s ability to resonate with the needs and limitations of trial participants on the one hand and the requirements of principal investigators on the other.
From a sponsor perspective, addressing this challenge implies proactively reaching out to patients to find out their comfort level with using a particular device, as well as their commitment to staying with it for the duration of the study. In the language of user experience design, this is the acceptability factor, which applies in equal measure to study staff and researchers, whose willingness may depend on the unique data processing specifications or other details that different wearable-clinical trial configurations may require.
A bird’s eye view
Above and beyond the barriers to mainstreaming the use of wearable sensors and apps in clinical research, the attendees of our workshop revealed the extent to which they were familiar with using sensor-derived patient-reported outcomes. The majority (60%) said they had some early experiences with a few such trials, about 30% admitted their organizations were in the planning stages but had not yet taken the leap, and only 10% recognized wearable technologies reflected a systematic approach to clinical trials in their organization.
Seeing the challenges related to wearables adoption in clinical trials in the light of moderate-to-low uptake of this new modality – despite the enthusiastic interest in it – underscores how important it is to resolve questions that are “putting a damper” upstream, such as the lack of clear standards around data protection and integration. In the meantime, the industry’s pent-up demand for modernizing clinical research and its own innovation and experimentation with sensor-derived PROs will surely help players gain confidence and hit the ground running as soon as the regulatory sky clears.