‘Everything to do with patient centricity’: Wearables to redefine research approaches

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/DragonImages)
(Image: Getty/DragonImages)

Related tags Litmus Health Thread Wearables Patient centricity Data collection Virtual clinical trials

After ‘holding its breath’ for nearly half a decade, pharma and health care companies are ready to implement new technology in clinical trials – though data standardization will be key to fully realizing the benefits.

For Sam Volchenboum, MD,​ a practicing physician and co-founder of Litmus Health​, more data means more ways in which to begin a conversation about a patient’s needs and experiences. This is especially true with wearable ​data, he said, which provides a more accurate picture of everyday life – enabling targeted care and advice that caters to a patient’s ‘reality.’

“[Wearables] have everything to do with patient centricity because they make the patient experience measurable and trackable in a way that was impossible before,” ​Volchenboum told us.

Said Sean Vassilaros, COO of Thread​, which uses wearables in several studies using the its platform​, “The keys to making wearables patient-centric is supporting the patient consistently to clearly understand the purpose of the device, easily receive/connect the device, understand the importance of the data it collects, and receive reminders to charge it throughout the study.”

Still, the industry has only ‘very recently’ reached the tipping point as it pertains to technology adoption, said Volchenboum, who described the past half-decade as a “’hurry up and wait’ game” for technology vendors.

“The vendors’ technical capabilities were ready, but pharma and health care companies themselves were not ready to implement. The industry was holding its breath for a company that would be the first to meaningfully incorporate emerging technologies and prove out use cases and overall value,”​ he said.

Over the last five years, Vassilaros said the company has seen a ‘large shift in perception and comfort level’ from its customers.

“Now that we have further evidence, publications, more case studies, metrics from complete studies and use cases in Phase II-IV studies and registries, we consistently witness R&D leaders in life science organizations who are looking to apply these patient-centric solutions as standards within their research approaches,”​ said Vassilaros.

Big players such as Eli Lilly, which partnered with Apple for a dementia study using the Apple Watch, are leading change and will be followed quickly by companies looking to adopt emerging technologies, said Volchenboum. “I wouldn’t be at all surprised if over the next year we see a lot of pilot studies and projects leveraging blockchain, artificial intelligence​, and wearables coming out of the industry,” ​he added.

Said Vassilaros, “As virtual visits are enabling studies to increase efficiency and potentially reduce costs today, we see this approach playing a significant role in driving change over the next five years.”

As part of the discussion about patient centricity, Volchenboum – also the director of the Center for Research Informatics at the University of Chicago and a board-certified pediatric hematologist and oncologist – said it is important to ‘step back’ and think about what needs to be done as it pertains to the patient pipeline.

“The majority of clinical trials do not have demographics that accurately reflect the communities they’re trying to serve,” ​he said.

“Part of achieving true patient centricity means that we’re also removing barriers to access in our clinical trial systems. Only then can have results that accurately reflect the patient experience in all its diversity and complexity.”

Another example of the move toward greater technology adoption, Sanofi recently hired its first chief digital officer, a trend Volchenboum expects will continue at other companies as they realize the potential of new tools, such as wearables and AI.

However, unless the industry can decide on standards for data collected from these emerging technologies​, any potential insights will be impeded – and adoption held back.

“I can’t even tell you how many trials I’ve seen where data standardization was only considered later in trial development — in the best case, this creates significantly more work for researchers. In the worst case, the data become impossible to work with and can sour a company on working with a new technology,”​ said Volchenboum.

“It’s imperative that we make technology adoption fruitful for researchers and their organizations, which I believe means making data standards a priority. I believe we need both top-down and bottom-up/grassroots approaches,”​ he added.

With its customer, Vassilaros said the company will continue to educate and drive adoption, “but ultimately the study sponsors are the key stakeholders that can drive this change to become a standard approach option in research.”

Regulators ​also need to lead standardization efforts creating incentives for researchers to “do the right thing.” Said Volchenboum, “There must be an environment where the easiest path will be to adopt and use data standards.”

In this same vein, researchers must create a ‘culture of data literacy’ and FAIR data practices: Findable, accessible, interoperable, reusable. “Only through both approaches will we truly achieve standardization throughout the industry,”​ said Volchenboum.

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