Decentralizing Clinical Trials With Wearables

Traditional vs Virtual Clinical Trials

Clinical trials are a necessary part of testing the efficacy and safety of new drug therapies, medical devices, and interventions. But these studies have long been viewed as challenging due to issues such as recruitment, retention, and high financial cost.

Many trials are terminated before completion–often due to low participation. While there are numerous reasons for this, one of the biggest is that traditional approaches have relied on onsite visits for assessments.  Some people simply don't want to participate in a clinical trial because it's a hassle, while others might have mobility issues or live in a rural area which makes it a considerable burden. 

With the development of continuous remote monitoring and the integration of cloud-based platforms like Labfront, wearable devices are fostering a new era of clinical trials. Although there isn’t unanimous consensus on the terminology, virtual, remote, decentralized, hybrid, or patient-centric clinical trials are all terms used to refer to clinical trials incorporating tech tools that allow part, or all, of a trial to be conducted remotely. Rather than focus too much on semantics, we’ll take a look at the use of wearables in clinical trials overall.

Wearables in clinical trials

Experts say over the next few years, there will be a meteoric rise in the use of wearables in research. Kaiser Associates and Intel estimate that by 2025, 70% of clinical trials will incorporate sensors.

A search of ClinicalTrials.gov shows that there are already over 1,300 active or completed studies using wearables. Actigraph (1,024), Fitbit (668), Garmin (84), Apple (52), and Empatica (47) are among the most common devices used in these studies. The types of data collected include–but are not limited to– heart rate, heart rate variability, activity, sleep patterns, respiratory rate, and blood oxygen saturation level. And when  looking at therapeutic areas using wearables, they are most frequently implemented in central nervous system, neurologic, heart, vascular, and respiratory tract trials. There are also a number of trials employing wearables for mental disorders. 

Benefits of wearables in clinical trials

Using wearables in clinical trials can potentially offer researchers several benefits such as:

Continuous real-time biometric data collection

In traditional clinical trials, measurements and adherence to study protocols can only be evaluated intermittently. This can obviously turn out to be a serious problem if there is inaccurate or missing data. Wearables enable remote, passive  24/7 data streaming which makes it possible to monitor the data in real-time and intervene if necessary.

Another advantage is that data can be collected continuously over a longer period of time, giving researchers a more complete view of a person’s health– as opposed to infrequent snapshots that lack real-world context. This can enhance understanding of the effects of treatments or interventions in a patient’s daily life. 

More patient-centric

In addition to offering benefits for clinical researchers, wearables can also provide significant patient benefits.  In a 2019 survey on patient preferences, most respondents reported that they would rather take part in a mobile clinical trial than a traditional trial, citing convenience,  eliminating travel to in-person visits, and perceived greater data collection accuracy.

Using wearables can also increase participant engagement by providing a way for them to see metrics that directly relate to their life and overall health that they may not have been aware of otherwise.

Additionally, compared to most of their medical-grade counterparts, consumer wearables are often lightweight and easy for patients to use, making them more comfortable for those interested in participating in trials.

As most researchers are well aware, happier patients equal higher adherence and lower attrition rates, reducing the risk of delays or additional recruitment. 

Lower overall costs

The use of wearables helps to reduce administrative costs by remotely monitoring compliance in real-time, scaling data collection, and reducing or removing the need for lab visits. Altogether these factors can reduce the personnel and time needed for clinical trials, bringing down the cost significantly.

Challenges of Virtual Clinical Trials

Even though there is a range of benefits from using wearables, they are not without their issues.  Accessing the raw data from some wearables can often be difficult, and how this data is organized (or in many cases disorganized in unintelligible files) after it's downloaded is a problem in itself. Then there’s analyzing all of that additional data once you get it. Add to that the concern about data security and privacy and it’s understandable why some researchers might be wary. 

Labfront as a Solution

Not ones to end on a bad note, we do offer a solution to many of the aforementioned problems. Third-party services, such as Labfront, work on making your research process much easier from start to finish.

Our partnership with leading device companies like Garmin grants us direct access to the watch sensors, allowing us to provide more granular data than any other consumer wearable on the market.

We provide your data in time-stamped, easy-to-use CSV formats that are organized for quick analysis and compatible with tools you’re familiar with, like Excel or Matlab.  Our expert data scientists also offer custom analytics packages to help you get the most from your data and accelerate your work. As Dr. Ann Hsing from Stanford put it, “The conscientious and hardworking Labfront analysts derived data that would have taken over a year otherwise.”

Labfront is also HIPAA-compliant and we strive to meet the leading standards for data privacy and security. The data is yours, period. 

The conscientious and hardworking Labfront analysts derived data that would have taken over a year otherwise.

Summary

Wearables offer a valuable way to complement more traditional methods of research that should not be underestimated. Not only can they save time, deliver rich real-world insights and reduce costs considerably, they also increase patient engagement and compliance by giving them a greater feeling of control over their health and well-being.

Ultimately, wearable tech is poised to make clinical trials better for everyone involved, from researchers to patients.