Connected digital products have steadily become more prominent among clinical research efforts since the start of the millennium, according to new data published Friday in NPJ Digital Medicine.

In reviewing every trial registered with ClinicalTrials.gov between the years 2000 and 2017, a group of Harvard researchers found the use of these tools increasing with a compound annual growth rate (CAGR) of 34%.

"The use of digital products to remotely monitor patients in clinical research is not new; in fact, some early digital measurement products, such as Holter monitors and continuous blood glucose meters, have been used in clinical trials for decades," the researchers wrote in NPJ Digital Medicine. "Yet, there is a dearth of data on how often and in what context such products have been integrated into clinical research – information that has implications for stakeholders across the research ecosystem."

TOPLINE DATA

Across the 18-year study period, the researchers found the number of registered clinical trials using these devices grew more than tenfold, from just eight trials in 2000 to roughly 1,170 trials in both 2017 and 2018.

In total, the team identified nearly 6,400 such trials – but notably did not include the 1,177 initiated in 2018 in their 34% CAGR calculation, due to incomplete submission reporting for the full year.

While these trials often took the form of evidence-generating studies, the researchers noted that approximately 13% were designated as an FDA-defined development stage trial or a phase 4 post-marketing study. (For reference, 52% of all ClinicalTrials.gov data during the time period were designated as an FDA-defined phase.) Meanwhile, 19% of the connected digital product trials had an industry sponsor or collaborator (compared to 34% of ClinicalTrials.gov's total records).

The researchers described an evolution in the types of connected products included across the years, with smartphone-enabled products and mobile apps spiking from 2015 onward.

They also laid out four primary connected digital product use cases for which these trials were designed: as a validation of the product's functionality; as a test of its clinical usability; to use the product as a data-collection tool for another intervention; or to measure the product as the primary intervention (à la digital therapeutics).

HOW IT WAS DONE

Before conducting an automated text search of ClinicalTrials.gov's database, the researchers identified a list of connected digital products using relevant product lists from the Scripps Research Digital Health Library, Elektra Labs' Atlas resource, the CTTI Mobile Technologies Database and Frost and Sullivan's 2016 Wearable Technologies Report. These were used to build search terms for each identified product alongside general search terms such as "smartphone" or "smart watch" when reviewing the database's registered studies.

In total, the team generated over 1,000 search terms for their review, but noted that some studies may still have been missed "because ClinicalTrials.gov does not require trial sponsors to disclose whether the data measurement tools used in the trial are connected digital products."

All trials included in the analysis must have at least begun to recruit its participants between 2000 and 2018. Researchers also reviewed a random sample from each year to ensure that their search was performing reliably.

THE LARGER TREND

The growing number of connected digital product clinical trials is clearly an important step for developers looking to validate their devices and software for broader use within healthcare, but these numbers also indicate a changing landscape for other major stakeholders.

"For pharmaceutical manufacturers and contract research organizations, the emergence of connected digital products into the clinical research space presents an opportunity to include novel trial endpoints that use real-world evidence," the researchers wrote. "For patients, connected digital products can reduce the burden of trial participation and increase the inclusivity of clinical research by fostering remote monitoring and encouraging the enrollment of individuals who might otherwise be unable to participate due to socioeconomic circumstances or travel limitations."

Digital clinical trials come in many forms, and several prominent pharma leaders have voiced their support for greater adoption of these technologies. The past few years alone have seen more than a handful of major digital-trial launches and completions from big names like Johnson & Johnson, Verily and Apple.

IN CONCLUSION

"To achieve broad adoption in clinical practice, verification and validation of connected digital products will be essential and, like other interventions, ongoing vigilance regarding their safety, efficacy, and usability will be valuable for clinicians and regulators. Future analysis in this area should explore in more detail the context in which different organizations are using connected digital products to bolster their research efforts," the researchers concluded.

Four years ago, Seattle Children’s hospital began its journey revamping its analytics system. The system originally went from a relatively siloed analytics platform to a dashboard that catered to the clinical, research and business side of operating. 

“The key thing to highlight is not only do we cover a broader set of the organization, a broader set of tools that are more predictive, we’ve also provided more and more training and education around how to use and do analytics and what are the ethical considerations as we do these things,” Ryan Sousa, the chief data officer at Seattle Children’s Hospital, said during a HIMSS20 Virtual Webinar.

But the change to this versatile platform came down to a lot of hard work and innovation. During a HIMSS Virtual webinar Sousa explains the 11 innovation mindsets that helped Seattle Children’s reach their goal. 

1)  Innovation is bold. Sousa said that when the analytics project first kicked off, state of the art was basic supply chain reporting and revenue cycle reporting. However, the team had a clear vision for the future, which included more predictive analytics, baseline monitoring and early detection.

“When we started this, we said we are going power the innovation that drives action to improve the lives of children and their families,” he said. “We weren’t shy about it. We were talking about we are going to build these new capabilities and stream this innovation in real time.”

2) Innovation is community. Sousa stressed the importance of bringing various stakeholders into the fold of innovating to cultivate new ideas and perspectives. 

“That is something we focused on really early,” Sousa said. “It was about getting the user community to come together, the analytics platform folks to come together, and ultimately bringing those communities together so we don’t distinguish between business and technology.”

3) Innovation is self-serve. Sousa said that empowering the end users to select the right tech and innovation for their uses ends up freeing up the analytics staff.

“The more powerful … after picture is that the physicians, the researchers, the administrators and executive leaders are doing increasingly an amount of self-serve,” he said. “So, more and more things that used to be done by analysts are done by the user community themselves. … Analysts now are becoming data scientists in our organization with some significant upgrades to training and skills.”

4) Innovation is diversity. Having a variety of viewpoints on a team can spark new ideas and ways of seeing a problem. 

“Everyone starts in their own place based on their own set [of] shared experiences but over time as they share notes and connect ideas, we start to align on something very different than any of us have thought about at the beginning,” he said. 

5) Innovation is connections. Sousa said that being able to socially connect to share ideas is key to innovation. He gave the example of networking events and hackathons as a way to connect with new ideas. While social distancing continues, he mentioned virtual happy hours as a way to get together and spread ideas. 

6) Innovation is curious. Sousa said it’s important to be curious, not just about new topics that interest you, but also about other people’s ideas and way of thinking. 

“It’s about being curious why someone feels strongly that you are wrong about something,” he said as an example. “So, if someone comes in with a strong disagreement. It isn’t about arguing back but saying help me understand more.”

7) Innovation is change. Innovation isn’t about changing systems in baby steps but rather rethinking the whole problem, he said. 

“You can chose to go after your technical challenge and make small improvements to existing processes and over time you will see incremental improvement,” he said. “Really if you want to drive transformative change it is about changing your thinking, it’s about moving away from how you’ve seen things in the past, not looking for ways to incrementally improve the process but redefining the whole thing.”

8) Innovation is believing. Sousa said that especially when starting a project having faith in the idea is key. 

“Four years ago, we were the best at [saying] 'Why we can’t make things happen?'” he said. “Instead of saying 'That can’t be done,' really focusing on how can we make it happen. That small change in mindset was very transformative in our journey.” 

9) Innovation is people. He noted that empowering the individual to be the changemaker was key. 

“How do you get people to engage and make it their own? That’s an important part,” he said. 

10) Innovation is hard. Sousa said that during the innovation process the leaders of the initiative often feel isolated and lonely. 

“The important thing is to stay focused,” he said. “Win or fail, knowing at the end of the day you did your best and are moving things forward is its own reward, and more often than not you will succeed.”

11) Innovation is you. Sousa stresses the importance of individual thinking when pitching new ideas for the future.