Piloting wearable sensor technologies for clinical trials

Measuring vital signs is a critical part of any clinical trial; it helps us to characterize diseases and the effect of our therapies. Wearable sensors have the potential to help us capture vital signs data more efficiently and with much more detail. Automating the remote collection of vital signs data in clinical studies promises to bring a wealth of benefits for patients, sites, study teams and project teams.

Before I explore these benefits, let’s take a look at how UCB’s Global Clinical Sciences and Operations (GCSO) Innovation has been working in this area as part of the Technology Transformation Implementation program.

Wearable sensor technologies: Walking in participants’ shoes 
The development of wearable sensors has reached a stage where non-intrusive products can measure clinical dimensions continuously and in the real world with sufficient robustness. And GCSO Innovation has been piloting two wearable sensor solutions to explore how they can help us measure vital signs more effectively in our clinical trials.

The pilot engaged our colleagues across the organization in the innovation process, asking them to ‘walk a mile’ in patients’ shoes. An amazing eighty volunteered to take part, of which 24 were selected to wear each of the two devices for seven days.

Putting themselves in the place of a clinical trial participant, our colleagues reported on the comfort and usability of the devices.

New opportunities for medicines development 
The COVID pandemic meant GCSO Innovation had to conduct the pilot virtually, which ultimately helped it learn about the potential for these devices in Decentralised Clinical Trials. With its final analysis complete and findings reported, GCSO Innovation concluded that “Devices capable of continuous data capture provide new opportunities for medicines development, and we were able to see a greater magnitude of granularity for physiological data”.

The report also revealed some important insights that UCB gleaned into operating clinical trials virtually and collecting continuous clinical trial data. Firstly, during the pilot, we learned that operating remotely presents new challenges to working with clinical trial participants. We are now considering how best to fully support participants in a virtual environment as we journey towards truly patient-centric clinical trials.

We also learned of some additional factors that we need to consider when we capture continuous data. These include device recharging times, loss of connectivity between the device and phone, how participants use or are challenged by these devices over time and their general comfort with these solutions.

Human beings are complex
But one of the most important things that we learned was that measuring physiological data continuously in a real-world setting presents a large degree of variability in measurements. That variability isn’t down to the underlying state of the participant but could instead be due to their extrinsic environment and activities of daily living.

In other words, human beings are complex creatures. The data that we continuously collect as participants go about their daily lives looks completely different from the data we capture in the controlled environment of hospitals during our clinical trials. We, therefore, need to understand what this complexity looks like and when measurement variations may naturally occur before we can maximize our use of these new tools.

Armed with this information, UCB study teams are now exploring how best to use wearable sensors in studies to benefit patients. 

Rapidly advancing knowledge for the benefit of all
This pilot sandboxed GCSO Innovation’s investigation into our use of their innovative solutions. Sandboxing allows the team to gain timely, cost-effective feedback to rapidly advance their knowledge on how we can use wearable sensors effectively. Moreover, it also de-risks those innovations before we introduce them into our clinical trials.

Ultimately, I hope to see more pilots like this in the not too distant future. Trialing innovations in this way is a win-win for everybody. It benefits our patients and healthcare professionals by accelerating innovations. It benefits study teams and project teams by allowing them to capture continuous data in real-world settings. And it benefits UCB and our small and medium-sized enterprise (SME) partners by making us a better partner in the innovation ecosystems.

Moreover, UCB is looking to establish true partnerships at every step of the pharma value chain. Our new patient-centered framework, for instance, provides our colleagues in all business functions with a tangible roadmap on how to create a mutually beneficial, truly inclusive pharma. Find out more in the interview of our Chief Medical Officer Iris Loew Friedrich in a pharmaphorum article on "Engagement to partnership: The changing face of patient involvement".