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Wearables have come a long way from being just a part of the support system for insomniacs and fitness enthusiasts. Today, they form a part of digital health technologies and are maturing into sensor-based wearables which gather real-time data for clinical trials. The insights they offer into a patient’s health and fitness stream in 24x7x365, helping clinical researchers track and measure novel, under-reported endpoints. Regulatory authorities around the world are happy to add them to their standard frameworks as tools that help gather patient data and have them integrated into clinical trials. These are, undoubtedly, exciting times.
Sensor-driven wearables are invaluable tools, set to revolutionize research and data collection in clinical trials. Given their ability to collect data at a highly granular level, wearables play a significant role in clinical trials collecting longitudinal, high-frequency data. Many decentralized and hybrid trials are underway, demonstrating the benefits of wearables in clinical trials. As of December this year, 1421 clinical studies involved the use of wearables, according to clinicaltrials.gov. With the impetus to digital transformation given by the COVID-19 pandemic, this trend is expected to only accelerate further.
As with all good things, benefits are followed by challenges, and this article tries to look at what they are and how they may affect the integration of wearables into clinical trials.
It is not enough to find a wearable which is efficient at collecting the required data. We should also factor in the limitations and preferences of trial participants if any. The device needs to be accepted by the participants, as they need to be comfortable with using it. Only the participants’ acceptance will drive the willing and consistent use of a device during the duration of a study. To ensure adherence, sponsors would do well to reach out to trial participants to gauge their comfort with a particular device before adopting it for a trial. Clinical study teams need to monitor all aspects of a wearable’s use in a trial from data connectivity, type of data, data privacy and security to the effective extraction of data and its processing and be assured of the accuracy and validity of the data before integrating it into their research. This approach is especially important when a wearable is a consumer-grade device.
Wearables impact the collection of data for clinical trials in many ways, even as they are evolving and improving in quality and efficiency to meet the expectations set upon them. The wearable’s size, battery life, impact on daily activities, regulatory approval status, and ability to meet the clinical trial endpoints with the required verification and validation are all points that will need careful consideration and evaluation. Trial sponsors’ choice of device/technology is primarily dictated by its data generation/integration capabilities which meet the parameters of the clinical trial. Adding an additional data source to a clinical trial needs to be done right, making the choice of wearable and its implementation crucially important. Some wearables today enable longitudinal biometric data sets, to provide unique insights into the effects of treatment protocols in the long term. Many wearables have their own proprietary algorithms and accessing the data collected by them, clinically validating it, and making use of it are challenges that need to be resolved, without forgetting the need to integrate it into the software that manages the clinical trial’s data.
Trial teams may see challenges when participants find the use of a wearable uncomfortable or difficult to manage. Allowing the participants to bring their own devices to a trial could increase patient engagement and reduce logistical complexities and improve adherence. But owned devices may not offer a uniform measure of patient-reported outcomes (PROs) across the trial in a manner compliant with regulatory requirements. This explains the reluctance of trial sponsors to accept BYOD as a strategy in clinical trials. Without software that is agnostic to the diverse operating systems used by the wearables, trials using patient-owned devices may require longer timelines.
Wearables record a lot of data, which needs to be processed and integrated into trial data and be reported. It needs to comply with the data privacy, patient consent for data collection and sharing requirements as well as the standards laid down by laws like HIPAA and certifications like HITRUST. By using licensed platforms which enable data management, companies can strategize to ensure data privacy and content validity even with wearables that are not fully compliant. Working with device makers to suitably customize the collection of clinical trial endpoints which can be validated may offer a way to resolve the challenges with data ownership and sharing, consent requirements, preservation of privacy, and security while adhering to specific regulatory requirements by region.
Technical considerations are important when including a wearable in a clinical trial, while regulatory considerations are essential. FDA cleared devices help to assure trial sponsors of data privacy and ownership, data accuracy, data security and adherence to trial protocols. Wearable devices and sensors today are improving by leaps and bounds to offer highly useful and insightful metrics, independent connectivity, more security and better battery life. Progressively, they evolve into fit-for-purpose devices and align with analytical clinical validation methodologies. For wearables to be accepted by clinical trials, their monitoring needs to be continuous, their data verifiable and their clinical insights meaningful.
Huge amounts of raw data collected from wearables need to be validated, processed and analyzed without affecting data security. Most data from wearables cannot be accessed directly and needs to be transferred to a mobile phone first before being directed to the trial database for interpretation. This flow of data presents significant challenges and could drive costs up if there are no failsafe mechanisms that prevent data loss. It is essential to have a system in place which enables the trial sponsors to monitor trial progress, movement of data, source documentation of data with audit trails. The system needs to be able to spot errors in real-time and initiate corrective action if needed.
Choosing the right device to monitor the targeted therapeutic area through timely intervention is also a very important aspect of employing wearables in clinical trials to derive meaningful digital endpoints. Sponsors must keep their clinical endpoints in mind when selecting the device, ensuring that they are able to measure what they need to. Many consumer-grade devices are available, but their design doesn’t specifically address a medical problem. Trial sponsors need to ensure that a particular device meets their requirements and employs appropriate terminology. There’s also a need to employ technology to process the massive 24×7 data collected by sensors, which is very different from the scheduled collection of data by teams at clinical sites.
Collecting data using high-frequency sensors becomes a way of life with the use of wearables in clinical trials. Integrating these data streams with data held by existing clinical systems is a challenge as it requires a customized solution based on the existing architecture, standardizing the integration of inputs in each case. Determine what data can be accessed and decide on a workflow for its secure transfer. Consider device-specific limitations of data, missing data from non-adherence, duplicate data and any inaccuracies in data for reliable data interpretation. All data submitted to regulators need to meet minimum standards in terms of validity, reliability, sensitivity and robustness.
All these challenges are more than offset by the benefits offered by wearables, which have proven highly beneficial when collecting clinical data, improving the effectiveness of clinical trials while reducing non-compliance and overall costs. They enable more observational studies and encourage new treatments and protocols, improving patient care with real-time insights. Patients are able to avoid periodic site visits while sponsors are able to redeploy personnel at clinical sites. It is indisputable that wearables offer innovative new approaches to clinical research and are set to modernize clinical research.
At MaxisIT, we clearly understand strategic priorities within clinical R&D, as we implement solutions for improving Clinical Development Portfolios via an integrated platform-based approach. For over 17 years, MaxisIT’s Clinical Trial Oversight System (CTOS) has been synonymous with timely access to study-specific, standardized and aggregated operational, trial, and patient data, enabling efficient trial oversight. MaxisIT’s platform is a purpose-built solution, which helps the Life Sciences industry by empowering business stakeholders. Our solution optimizes the clinical ecosystem; and enables in-time decision support, continuous monitoring over regulatory compliance, and greater operational efficiency at a measurable rate.