Wearables in Clinical Trials: Opportunities and Challenges

Wearables have shown the potential to significantly impact the data available for clinical trials and medical researchers in numerous ways. While the quality and efficacy of these devices can vary, the sensor technologies in these devices have evolved to meet the needs of many clinical research endeavors.

Wearables also enable longitudinal biometric data sets that can provide unique insights into the long-term, real-world impact of pharmacotherapies and treatment protocols. There are also many challenges in using wearables in trials, including access to the raw data from wearables, validation of the data from wearable devices, processing and analysis of massive amounts of wearable data, and data security.

Let’s take-a-look at the state of wearables in clinical trials and medical research, and where there might be future opportunities and challenges that need to be overcome.

Opportunities and Potential Benefits of Wearables in Clinical Trials

The increasing interest in clinical trials is being driven by the benefits that can be received by both the sponsor and patient. This is due to the effectiveness of wearables in collecting new and objective data that can be done in an easier way while at the same time lowering overall costs and improving the effectiveness of the trials.

Using wearable devices in a-majority-of these trials has shown to improve effectiveness by lowering the clinical site time and the personnel needed for those sites. Having the data available before the patient visits the clinical site also allows personnel to make earlier decisions and provide faster alerts to non-compliance when patients are not in the clinical setting.

Data aggregation from wearables also provides a multitude of opportunities for more observational studies that have not been possible before. This can lead to new hypotheses for future interventional studies that can be used to improve patient care by providing new treatments and protocols.

There is also the potential for more insightful patient phenotyping, which includes improving inclusion and exclusion criteria needed to demonstrate efficacy and safety more efficiently. When a device can be used across multiple trial phases, it is possible to increase the efficiency of post-market studies as well.

On the patient side of things, wearables will provide a way of seeing metrics that directly relate to their life and overall health that they may not have been aware of otherwise or even had access to. There is also a reduction in the burden of the patient to spend large amounts of time in clinical settings undergoing additional testing and visits to specialists, which can also lower costs associated with medical care.

Wearables in Clinical Trials

From the numbers pulled from clincaltrials.gov, we can see just how many studies are currently being conducted using wearable devices. From a high level, there have been about 1,400 trials conducted, with about 540 of those that have been completed. The remaining trials (around 880) are still active is some form. What’s interesting too is that these numbers do not include studies that have been suspended, terminated, or withdrawn.

Of the 1,400 clinical trials that are active or completed, the most common wearable devices that have been used in the studies include Actigraph (594), Fitbit (353), Garmin (32), Apple (23), and Empatica (19). The functionality of these devices and the kinds of data being feed in the database to be analyzed in these clinical studies include activity tracking, heart rate, heart rate variability, sleep, glucose monitoring, haptics, sweat analysis, electro-stimulation, UV tracking, and pressure sensors. While a majority of the studies relied on activity tracking to record things like energy expenditure and steps, other biometric data is starting to see an uptick in how often it is being included in these studies.

The therapeutic area these studies used wearable devices for most frequently was cardiovascular. Others than were commonly used include:

Neuroscience
Respiratory
Sleep
Stress
Metabolic disorders, including diabetes and obesity
Rheumatology
Pain

Challenges & Considerations for Wearables in Clinical Trials

Adding wearables to a clinical trial has the potential to raise costs depending on the type of wearable used, what data you’re trying to get from that wearable, the infrastructure needed during collection, and the number of participants needed. Patient adherence rates also needed to be monitored in most cases to ensure data is collected as expected.

While wearables devices are essentially data collection endpoints, what you do with the data coming off the device, how the data is being transferred to other devices (such as a smartphone), and how that device sends information to the trial database for interpretation are challenges presented in the flow of data across multiple platforms. Access to the raw data from wearables can often be difficult to come by, and how this data changes after it comes off the wearable device is also a challenge. When wearables are included, processing and analytics also have the potential to drive costs up because of the additional data.

In terms of security, the device and the data as if flows through the database need to be secure in a closed-loop, and the costs associated with making this happen are further considerations that must be made for clinical trials. How the device is measuring what is says it is measuring, and the acuity and accuracy of that data as it relates to the data that supports an endpoint is critical.

Other things to consider are the devices of technical characteristics. Size, convenience to wear, battery life, and impact on daily life activities of the user are variables involved in the clinical study. Regulatory considerations must also be made, which include any marketing or labeling claims requiring support by an FDA cleared device. Engagement with regulators is also critical early-on in the study development to make sure the needs of meeting the endpoints are met and have the right amount of verification and validation to enable it to support claims being made.

Outside of sponsor challenges and considerations, from a patient perspective whether-or-not, they will have ownership of data from a trial and all aspects of privacy should be clearly defined in the study protocol and communicated to all involved.

Guidelines for Wearables in Clinical Trials

There are few initiatives that have provided a valuable framework for guidelines for wearables in clinical trials. One of these is the Clinical Trials Transformation Initiative (CTTI), which has produced a recommendation for the usage of mobile technology like wearable devices.

One of the important parts outlined in CTTI is the initial selection, which explains that you should know what you want to measure before selecting the wearable device. Starting with the endpoint and working backward will ensure you select the right device and avoid problems down the road.

Also of note is the regulatory status of mobile technology, and the CTTI states that it should not be the sole driver in the sponsor’s decisions about which technology to use. The appropriateness of that technology should be justified through the verification and validation processes. From a data collection, analysis, and interpretation standpoint, collecting the minimum data set necessary to address study endpoints is critical, as is planning appropriately for the statistical analysis of that data.

CTTI’s stance on data management states that you should ensure that access to data meets your needs prior to contracting an electronic service vendor. For protocol design and execution, communication and transparency with participants regarding safety monitoring is also a critical element during testing. Other key points include defining and testing processes for implantation, operation, and maintenance in the field prior to launching a trial as well as having a plan in place for mobile technology failure.

Finally, one other recommendation that’s worth highlighting from the CTTI is the process of FDA submission and inspection. The key point here is that the data capture should be readily reconstructed. Things like where the source data comes from, how does it move from the device to the trial database, source documentation on the data, and audit trails all the way through are essential components that sponsors should ensure during clinical trials of wearables.

The Critical Path Institute (C-Path) ePro Consortium is another valuable initiative that offers recommendations for using wearable devices in clinical trials. One of the highlights in this particular guideline is to identify a device that’s fit for purpose in measuring the identified concepts of interest within a clinical trial or drug development program that requires consideration of three factors. These include:

Is the wearable device or sensor safe to use?
Are the device and vendor suitable for the trial objectives and patient population studied?
Is there satisfactory evidence of data validity and reliability to confirm that the device provides content validity, reliability of assessment, and concurrent validity?

The C-Path also identifies the need for evidence to establish clinical trial endpoints that are derived from wearable data. This includes the ability to detect change, interpretability, and the primary, secondary, and exploratory endpoints.

Next Steps Moving Forward

From the sponsors’ end, proof of concepts (POC) will continue to be used to test and validate the feasibility of wearables in studies. This is important not only for new capabilities but also for getting a validated verified look at how individual devices work for any given trial. Sponsors of studies should also continue to work with device makers to evolve endpoint data collection and validation.

Moving forward for devices and sensors, expect to see continued health-related advancements in wearables and the evolution of wearable systems designed specifically for clinical research. This involves getting more advanced metrics out of the sensor modules that are added into wearable devices, which is a path to getting more useful data and insightful metrics. Wearable systems will also continue to evolve, and this includes not only the device itself but battery improvements, independent connectivity (LTE), and improved security frameworks.

Patients are also a critical component in clinical trials and need to continue to get individuals to sign up and contribute data is important for the ability to conduct more studies. Of course, privacy will always be a concern, and patients will have to decide how comfortable they are sharing personal information with those involved in clinical trials.

Last but not least, regulatory environments will need to maintain a balance of regulatory clarity and flexibility in order to try new technologies in the clinical trial process. Further development of analytical clinical validation methodologies and the wide adoption of devices according to the fit-for-purpose principle will remain critical for future success.