Wearables for clinical trials - where do they fit?

Clinical trial methodologies are an increasingly debated topic, especially around how to improve the patient experience. This has led to the introduction of new technologies that potentially modernize the process and make drug development more accommodating for the participants. There is progress, but companies are slow to deviate from traditional methods. The COVID-19 pandemic, however, has forced CROs and sponsors to rethink their strategies, leading to a direct-to-patient approach, and opening our minds to future possibilities.

An innovation that has taken the fitness world by storm could also have legs in largely decentralizing drug development. Wearable technologies are a relatively new concept in clinical research, but one that is increasingly gaining traction, as they can significantly reduce patient burden while greatly increasing the volume and availability of data.

WHAT ARE WEARABLES?

Wearables are smart electronic devices that are worn to measure different datapoints – certainly not a new concept, with consumer markets flooded with an abundance of products. But, more recently, their application in collecting health-related data, especially in clinical trials, is being looked at more keenly. Wearables provide the ability to collect a multitude of datapoints – such as sleep quality, blood pressure, pulse rate, oxygen saturation, blood glucose levels, BMI, temperature and more – directly into digital format and, in some cases, neatly compiled into one application. A patient wearing a device continually and automatically records this information 24/7. This deluge of data can be stored in the cloud, then accessed, analyzed and compiled remotely anywhere worldwide.

DATA OVERLOAD

An endless stream of live data from trial participants would surely quench the insatiable data-thirst of every clinical statistician and data analyst. But what’s the next step? What to do with all this data? Personalized biometrics are useful, but they’re not objective endpoint data, and this is the big question surrounding the use of wearables in clinical trials. The enormous amount of information generated – at a relentless pace – then needs to be analyzed, and analyzed for a purpose. This is the gap that needs to be addressed.

THREE BENEFITS OF WEARABLES

1. Increased participant safety

Wearables can offer huge improvements to current practices. Having real-time information on trial participants would allow CROs monitoring the study to see potentially threatening health issues as they happen and swiftly intervene. Small changes in vitals or intermittent episodes may be missed between visits to the clinical trial site, but constant monitoring offers the chance to identify these symptoms before an adverse event occurs. This could make drug development safer for all.

2. Improved patient experience

Wearables also show promise in creating a more comfortable environment. By decentralizing clinical trials, the burden for patients is hugely reduced, which vastly improves their baseline experience.

3. Simplified and cost effective

The COVID-19 pandemic forced CROs to rethink strategies as participants could no longer visit clinical trial sites. Nurses collected observations and data from their homes – a significant leap in the patient-centric direction – but this proved time consuming and expensive. Wearables, however, could simplify the entire process, from data recording to collection, making it easier for the patient, and more economical for the sponsor.

WOODLEY'S EXPERT OPINION

Once the ‘data deluge’ questions have been answered, and CROs determine exactly how to use the waves of information, we feel that wearables will have a permanent place in clinical research. The regulatory concerns would need to be addressed, but that’s nothing new for us. And wearables certainly play to our strong suit in handling hardware, equipment distribution and ongoing technical support. In fact, Woodley already has a CGM system, the Dexcom G6, in our portfolio, which transmits real-time readings to a touchscreen receiver or smartphone, and is the first example of a wearable technology that sits alongside our range of rental equipment and solutions. Steve Karuppan, Senior Vice President - Global POC Solutions, explains: “The value of wearables in clinical trials will ultimately be assessed by what is done with the collected data. The solutions that enhance patient safety and access, and/or save time to drug approval, will prevail.”

There’s no doubt we are seeing a shift in the way clinical trials are being managed, and the COVID-19 pandemic has accelerated this transition. The complexities of running a clinical trial are well established, but wearables show promise to solve some age-old issues and encourage participant engagement. The endless stream of up-to-date information could be invaluable, but to what end? Indeed, a space to watch.

If you are interested in finding out more about our wearables product availability, please get in touch.