Improving diversity in clinical trials is a top priority in the life sciences industry, and rightly so. One-to-one representation of the population intending to use an investigational therapeutic is not just morally right, but also fundamental to its effectiveness. One of the biggest barriers to trials for underrepresented groups is access, largely caused by geographic and socioeconomic disadvantages. Connected sensors, especially as part of a decentralized clinical trial (DCT), are a key component to improve patient access as well as patient retention over trial duration.

According to clinicaltrials.gov, there were more than 1,380 trials utilizing wearables as of November 2022.[1] Experts predict 50% of clinical trials will incorporate wearables and sensors by 2025, against the 15% at present, and the market value of wearables and sensors is estimated to be $38.6 billion with a CAGR of 19%, reaching $54.6 billion by the end of next year.[2]

Wearable and sensor technologies have evolved into reliable products for a variety of uses including monitoring stress levels, activity, sleep, blood pressure, glucose levels, emotions, eye movements, and oxygen saturation and for carrying out electromyography (EMG) and electroencephalography (EEG). These range from medical-grade, FDA-cleared devices to consumer technology, which continues to mature.

The number of connected devices worldwide has more than doubled in less than five years to 1.1 million.[3] However, adding connected devices to trials must be done meticulously. Skip steps and devices can add complexity rather than improve data collection and patient experience. There are still several challenges associated with the use of connected sensors, including the following:

• Siloed Data
• Poor Patient/Site User Experience
• Device Failure
• Regulatory and Logistical Challenges
• Syncing of devices and data quality

“Millions of patients are becoming more comfortable using connected devices, which can transform health care but only if we approach their use strategically,” says Antoine Pivron, head of health solutions at Withings. “Pre-work is essential. Start by aligning with all trial stakeholders around the advantages and limitations of the device—and this includes the trial participants. Quality training is also critical.”

Benefits of Connected Sensors in Clinical Trials

Connected sensors can offer significant benefits to both patients and clinical trials sponsors.  They allow patients to participate in a familiar environment and help limit unnecessary travel to study sites, reducing patient burden and increasing retention.

Sensors allow collection and access to patient data in a more objective, accurate, and frequent manner, enabling a more holistic view of the patient’s health in day-to-day life (vs. infrequent site visits) and reducing the impact of white-coat bias.

Connected sensors allow trials to gather real-world data with a cadence driven by biology. This requires rethinking how we have historically defined endpoints and looking toward more functional outcomes that can be more meaningful than the results of a point-in-time lab or physician assessment.

Clearly not all endpoints can, or should, be measured at home. The key is determining endpoints that can be obtained from a patient performing daily activities that correlate with the trial, as well as those that provide a more granular picture of the disease trend.

Integrated sensors and standardization allow for better patient oversight by providing site partners with an accessible, secure, and comprehensive view of a patient’s health during a trial, allowing more timely management of task completion, remote monitoring, and the protection of patients. It is important, however, to provide sites with clear training so they don’t feel inundated with new devices to monitor without any support.

Sensor integration onto a single platform enhances the patient experience with seamless in-app reminders and task notifications, ultimately resulting in better protocol compliance and more consistent evidence generation. The aggregated data streams, in turn, provide more actionable insights, as they can be further analyzed to identify trends, establish correlations, and generate clinical insights in a timely manner (e.g. leveraging composite vital readings to identify interesting digital biomarkers or reactions).

While these are powerful benefits of connected sensors, the most significant benefit remains the ability to bring trials to more patients by literally taking the trial into their homes.

Case Study: Sensors Improve Patient Experience & Health

A top pharmaceutical company wanted to increase the safety of patients during an oncology trial. Anti-cancer treatments may impact lung function, ranging from asymptomatic radiological changes to respiratory failure. An assessment of lung function is performed as part of the regular visit schedule, which could range from weekly, during dose escalation and monitoring, to every 30-90 days throughout the ‘follow-up period.’ Given that these patients are already ill and often fatigued, this additional visit poses a travel burden that could cause a skipped visit, opening the patient up to worsening side effects.

To address this issue, the team deployed a Bluetooth pulse oximeter device to each patient during the trial. Patients clipped the device on their fingers for less than a minute each day to read their oxygen saturation. The sensor connected to an app that sent the data automatically to the site clinician. If the measurement was indicative of a change in lung function, follow-up questions were automatically pushed out to the patient, and if those responses required attention, the patient was immediately called in to treat the problem.

This allowed the team to catch potentially life-threatening medical issues at the very first signs with very little burden on the patient. Further, the investigator got a much broader view into the patient’s daily life and how they were responding to the novel treatment.

In addition, the company was able to expand access to the trial. The pulse-ox device kits were shipped across the globe to 24 different countries, including study sites in Europe, Asia, and throughout North America.

Six Steps to Assess Use of Sensors in Clinical Trials

One of the biggest mistakes companies can make when adding connected sensors to a clinical trial protocol (and this may seem counterintuitive) is to start with the device. In other words, don’t start by specifying a type of device to use, rather, start by clarifying what you want to measure: the endpoint.

By reverse-engineering the trial protocol, sponsors are in a much better position to succeed. Consider what device would be best suited to measure a specific endpoint first, then assess various devices based on quality, usability, geographic or cultural considerations. For example, if measuring a primary endpoint, sponsors will want commonality in devices across all countries for consistent data collection. So, for a global trial, conduct a country-by-country assessment for each sensor to support access and inclusion of patients, local regulatory requirements, and logistical management.

After careful consideration of the endpoint being measured, assess the device based on best-in-class performance across the following criteria:

1. Science and innovation
2. Data quality and data flow
3. Durability and reliability
4. User experience
5. Engineering maturity
6. Supply chain robustness

“Ease of use to ensure the device is aligned with the profile of the trial participant is one of the most important considerations and key to participant retention,” says Pivron. “For instance, if the majority of participants are elderly, then select a device that is intuitively designed for tech novices.”

Digital Biomarkers Mark Our Future

Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables, or digestibles. They support patient health with ongoing monitoring and rapid intervention when a problem is identified. With connected sensors rapidly evolving, the future of clinical research may be defined by digital biomarkers.

“Digital biomarkers help researchers better understand disease by generating additional data points. says Pivron. “This passive data collection, where patients are barely even aware of it happening, will become the standard in decentralized trials in the coming years. And it will be transformational, not only to how trials are done but also to how patients are treated.”

References:

[1] Clinicaltrials.gov, National Institute of Health’s U.S. National Library of Medicine (Accessed November 22, 2022). See full resource here.

[2] Clinical Leader, “Wearables & Big Data In Clinical Trials — Where Do We Stand?” by Y. Jansen and G. Thornton (February 2020). See full resource here.

[3] Statista, “Number of Connected Wearable Devices Worldwide from 2016 to 2022,” by Federica Laricchia (February 14, 2022). See full resource here.