For clinical trials, the road to results is often long and tedious – not to mention costly and resource intensive. Four digital health technologies are now poised to enhance and streamline the clinical trial process. Whether enabling more comprehensive monitoring, increasing the frequency of data collection, or growing the pool of potential participants, digital tools can help researchers reduce costs while improving efficiency and outcomes.
Wearable fitness devices
“Wearables” are small electronic devices that are light enough to be worn or carried. Through sophisticated technology (multi-axis accelerometers), they monitor things like steps, active minutes, heart rate, sleep and so on. In the near future, they will also provide measures and insights for stress levels and blood pressure.
There are two types of wearables found in clinical trials – consumer-grade and clinical-grade. Consumer-grade are the devices with which most people are familiar – Fitbit and Apple Watch, for example. They are relatively inexpensive and easy for people to use, so they tend to fit seamlessly into participants’ daily lives. That said, the data they generate is not yet considered clinically valid, and thus can only be used in an exploratory fashion during a clinical trial.
Conversely, researchers can employ specialized clinical-grade wearables, commonly known as actigraphs, to gather primary and secondary data. Although these devices resemble their consumer-grade counterparts, they have gone through the FDA 510(k) pathway and yielded validated data. As such, regulators consider them to be reliable enough to support safety and/or efficacy claims.
There are several advantages to leveraging wearables during a clinical trial. First and foremost, they let researchers closely monitor patient activity outside of the clinical setting – something that has not been possible to date. For instance, in a study that measures functional status, sponsors traditionally have had to rely on snapshots of the patient’s health gathered during a visit to a study center. Now, trial leaders can turn to wearables to continuously gather data, reducing the need for participants to come onsite. Not only does this lower the patient’s participation burden, it can also shorten the duration of the trial and reduces sponsor costs.
Real-time wearable data also gives researchers the ability to make amendments to protocols and make critical decisions based on someone’s readings. They can also detect signs of a problem earlier and respond accordingly, making the trials safer for those involved.
Clinical devices collect data and are used to diagnosis diseases or monitor conditions. Common examples include blood pressure cuffs, glucose meters, sleep devices, spirometers and weight scales. Clinical devices are widely accepted by regulators because they are able to provide accurate and defensible information – most devices are Class II and follow the 510(k) pathway.
In recent years, digital technologies have emerged that build on the functionality of well-established clinical devices, resulting in tools that retain the ability to gather regulatory-grade data but are more convenient. For example, innovators have developed blood pressure monitors that do not require patients to come on-site to have their blood pressure checked or to download data from a home machine. These wireless devices allow data to pass instantaneously from a cuff to a smartphone and into the clinical trial’s platform or system. As with wearables, when researchers use these technologically advanced clinical devices during trials, they make it easier for participants to passively participate, improve the reliability and frequency of data collection and limit the likelihood of incomplete, inaccurate or lost data.
Sensors detect and measure physical properties and record or respond to the input. Although sensors are found in wearable devices, they also play a larger role in health technology. In fact, sensors are currently being used to measure a variety of physical properties that were previously difficult or impossible to track.
Smart medication bottles are probably the most common type of sensor used in clinical trials today. These technologies tell researchers if a patient took medication and when that occurred, allowing them to better understand a patients’ adherence to treatment protocols. This can more accurately highlight whether variations in test results stem from lack of compliance by the test subject. Historically, the only way a clinical trial researcher could know for sure if a patient took the medication according to the protocol was to have the patient come to the testing site for administration. With sensor-driven technology, patients can self-administer with the same degree of reliability, reducing patient inconvenience while still preserving the accuracy of the study. In the future, we will see more sensors embedded in the pills themselves, with innovators like Proteus leading the way.
Designed to run on mobile devices, such as smartphones and tablets, software applications are helping patients better manage their health by tracking a plethora of factors, including heart rate, sleep, fertility, physical activity, weight and even certain disease symptoms.
There are two ways in which researchers use mobile applications in clinical trials. First, pharmaceutical companies are leveraging companion apps, which are designed to be paired with medications. Sponsors use the apps to communicate with participants via reminders and focused education, which appear as alerts on users’ smartphones or tablets. These apps improve communication and promote better engagement.
Second, sponsors are using mobile applications to recruit trial participants and monitor them remotely. In these cases, the app becomes the primary interface between the participant and the study. Instead of enrolling at a clinical trial site and visiting it periodically to interact with the research team, participants go through the entire process remotely. Not only does this make the process convenient for patients, it also substantially reduces the cost of the trial and facilitates more real-time communication.
Digital technology is a rapidly advancing field. By staying on ahead of the innovation curve, especially regarding the aforementioned technology, researchers can find ways to optimize their clinical trials, making them more effective, efficient and participant friendly.