Smaller, smarter devices for global trial diversity

For some time now, there has been talk about democratising clinical trials. Put simply, researchers understand the need to meet patients where they are, whether that means locating trial sites in underserved communities or leaning into digital tools that better reflect patients’ everyday lives.

The intention has always been good, but the execution has been challenged by technology that was historically expensive, difficult to set up, and operationally complex. For connected devices in particular, two challenges have stood out:

1. Global reach was costly. Smaller satellite-connected devices were historically expensive to provision, difficult to recharge and complicated to configure and deploy consistently across dozens of countries. Sites with deep infrastructure — think clinical-grade equipment in hospitals or labs with dedicated IT departments — were well-positioned to handle that complexity. Sites without those capabilities risked being excluded from studies as a result.
2. Devices were “nice to have”. Device feasibility has historically been a conversation that happened after sites were selected and protocols were signed, with sponsors bolting connectivity solutions onto study designs after the fact, rather than planning for them up front. Suddenly faced with the logistical challenge of supporting devices with clinical-grade accuracy at “real world” sites without clinical infrastructure, many sponsors found those devices just weren’t feasible in a trial context.

So, what’s changed?

Three words: Smaller, smarter, cheaper.

Things are changing fast. Consumer device giants are surging into the healthcare arena to make devices cheaper, more compact, and easier for patients to use. Those conducting a global trial just a few years ago may have had to manage multiple devices across countries due to import restrictions, regulatory laws, or data compatibility issues. Devices would be clinic-grade and durable in well-resourced countries, while researchers elsewhere may have had access only to second-tier vendors with completely separate data output formats.

As connected device vendors continue to drive hardware size down and make sensors smaller, these medical devices are starting to resemble consumer electronics that people already own. Wearables today look more like someone’s personal smartwatch than clinical instruments. Increasingly, wearables offer multi-day battery life, wireless syncing capabilities, and charging practices patients are already familiar with. Shrinking hardware sizes have two effects:

1. They’re cheaper to procure and deploy. Devices that fit in your pocket, rather than your closet, are far less expensive to buy and ship, particularly at the scale studies demand. Sites previously strained by the cost of shipping and provisioning are now able to afford sleeker, portable alternatives that cost less than a typical laptop.
2. Patients are more likely to wear them. There’s a familiarity to devices that look and charge like phones and laptops patients already own. Few patients think of wearing an Apple Watch as a trial requirement. Those subtle design choices matter. Patients are more likely to use wearables that seamlessly integrate into their daily routine than ones that get returned at check-out.

When you can send the same device, configured the same way, to dozens of countries around the world, you can expect consistent data by design. That matters when regulators evaluate whether data from a device can support a safety or efficacy claim.

Device feasibility is becoming a deciding factor in site selection

Historically, sponsors would look at whether a clinical site in, say, Southeast Asia, Latin America, or sub-Saharan Africa could participate in a global study and focus primarily on patient availability, investigator experience, and regulatory readiness. Whether the site would be able to support the devices needed for a protocol was an afterthought. Sites would be excluded because regulators didn’t accept data from those devices, or worse, sponsors learned late in the evaluation process the site didn’t have access to the device needed to collect certain data. Sites would be excluded from trial protocols for reasons unrelated to their ability to provide high-quality data from patients.

Not anymore.

Devices are now becoming a primary evaluation criterion, rather than a footnote in site selection. As connected devices continue to shrink in price and more data capture can happen remotely (rather than through tethered hardware only found at clinical sites), sponsors are increasingly treating device feasibility as a primary variable in site selection. Sponsors who build device enablement into early feasibility questions are finding it possible to responsibly expand trials into new regions that better represent the ultimate population a treatment will serve.

Consumer devices are graduating to primary endpoints

Connected devices from consumer tech giants have been involved in clinical trials for years. Patients would wear them; clinics would extract that data and use it for supportive or exploratory endpoints. But there was a soft cap on how much regulators would consider those devices for “hard” endpoints. A consumer-grade blood pressure cuff alone doesn’t provide enough data to verify that a medicine successfully lowered blood pressure. Those devices weren’t built with that in mind.

Increasingly, vendors are doing the validation work needed for regulatory confidence. Sensors become validated to regulators’ standards, and algorithms are verified to ensure they produce clinically actionable data that is accurate and reproducible enough to support a medical claim. Suddenly, these devices can serve not only as exploratory or supportive endpoints, but can also be used for pivotal clinical trials.

In practice, this has two huge implications. First, studies that can rely on validated, consumer-grade hardware that fits comfortably in patients’ homes is far less expensive and operationally complex than trials built around expensive, clinical-grade equipment that needs to be returned to the lab after each use – not to mention clinical equipment that requires facilities with dedicated hardware and training just to operate. Second, trial models that were once constrained by device limitations can now be reconsidered. Hybrid and remote trial models run more smoothly if the devices feeding data into regulatory submissions are already validated by regulators.

From point-in-time snapshots to continuous data streams

In the “old days” of trials, patients would visit a clinic, record data in a corner of the clinic, and leave. Period. Capturing data collected at one moment in time and extrapolating that to represent how a patient may feel week to week was never ideal, but that’s how many trials worked. Connected devices enable true longitudinal studies and true continuous data capture. A clinic visit captures one data point. Continuously monitoring blood pressure, glucose levels, patient mobility, et cetera, paints a more accurate picture of how a patient is doing. Continuous captures allow researchers to identify trends and variations that single snapshots cannot.

Beyond allowing researchers to paint a better picture of patient health, continuous data unlocks digital endpoints that simply didn’t exist before sensors got small enough to allow continuous measurement. It’s showing up across all therapeutic areas, but companies researching GLP-1 and obesity are facing a huge need for longitudinal body composition data. The problem is that DEXA scans, the current gold standard for body composition monitoring, are point-in-time measurements, not continuous, and are expensive, facility-bound, and often inaccessible to patients for hours on end. Portable, smaller, lower-cost alternatives can enable validated endpoint collection at a fraction of the price and can be easily shipped to sites and homes, which was previously not possible.

But none of that matters if patients and sites don’t have a consistent, streamlined way to interact with devices. First, there was Facebook. Then, Apple’s unified login popped up. Suddenly, logging into 10 different websites wasn’t 10 passwords. It was one. Device platforms have had to adapt and evolve to support multiple devices with a similar approach, using single sign-on.

Integrated dashboards give study teams a single view into a study’s overall health and a patient’s compliance and endpoint data performance. Platforms have had to step up to support the explosion of devices, allowing patients, sites, and study teams to consume data from multiple devices without feeling overwhelmed by 12 different login portals. Additionally, these large-device data sets can be used to visualise endpoint interactions, providing new insights into patient health.

Why this matters now

All these trends mentioned above are colliding right now. Record interest in the GLP-1 and obesity space is creating demand for real-world body composition data that sponsors are struggling to supply. Rare disease research depends on finding patients in geographically diverse regions, making data-capturing devices non-negotiable. Mobile, durable devices that patients can use anywhere are table stakes. On top of that, regulators across geographies are re-evaluating device privacy and security standards, in some cases creating divergent requirements that will need to be baked into device planning upstream. Sponsors that make smart device selection decisions now aren’t just investing in this year’s budget, they are determining whether clinical datasets will be diverse, representative, and high quality, enabling faster insights, higher patient compliance, and lower study risk.

About the author

Mike Bruhns is the senior director and commercial lead for connected devices at IQVIA. Bruhn’s more than 20 years of experience spans various industries. He is passionate about optimising solutions and creating novel and transformative solutions to build the broadest, most innovative portfolio of medical-grade device solutions for use in global clinical research, across all service lines, modalities, and therapeutic areas.