What’s really happening with clinical trial innovation?

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The clinical trial landscape has evolved significantly in the past two years. But given the quick embrace of decentralized clinical trials and growing traction of apps, digital health and other technologies in the space, it can be difficult to separate hype from reality.

To learn more about the evolving landscape, we caught up with Libbi Rickenbacher, director of strategy at 4G Clinical, to discuss the ongoing impact of the pandemic, decentralized clinical trials and other relevant trends.

Radical shifts in clinical trials?

The pandemic has undoubtedly disrupted clinical trials, leading to delays and outright cancellation of scores of studies. It may seem like a radical shift, but there was also self-preservation at work, Rickenbacher said.

“For some of those studies, maybe it was better for them to cancel,” she said. “It was very unfortunate for the patients, but you could argue that it could make a lot of sense to put things on hold and cancel for many early studies and some later-phase studies as well.”

Libby Rickenbacher

While the direct-to-patient clinical trial model existed before the pandemic, it helped some sponsors salvage clinical trials. “I wouldn’t call it a radical shift either – more of a response,” Rickenbacher said.

Conversely, the rapid growth of the decentralized clinical trials (DCT) market has been more pronounced. A handful of companies such as Science 37 (NSDQ:SNCE) and Medable (Palo Alto, California) have profited handsomely from the industry’s embrace of DCTs.

The interest in DCTs represents “a radical shift in terms of attention, and maybe the opportunity it offers for supporting trials differently,” Rickenbacher said.

The role of technology in patient-centric trials

The rise of DCTs has led to a surge of apps and, in some cases, digital health technologies that collect data in clinical trials.

Such apps can help track patient engagement, retention rates and health metrics. Similarly, the health-tracking capabilities of smartwatches are growing more sophisticated.

Sponsors planning on using such technologies in clinical trials should think carefully about how trial participants interface with them and the data they collect. If, for instance, a clinical trial is monitoring blood pressure remotely, sponsors should have a comprehensive plan in place for responding to blood pressure alerts.

Clinical trial designs calling for extensive patient engagement via apps or wearables should ensure usability is a priority. “Age is a huge component here when we’re thinking about these wearables and getting the appropriate telehealth in homes,” Rickenbacher said.

Sometimes, flexibility is needed. Patients in a clinical trial could benefit from having options of being dosed at home or the clinic, depending on their preference. “It sometimes makes a lot of sense for us to be able to choose,” Rickenbacher said. “Patients are more empowered when they know what is available.”

Of RWD, RWE and blockchain

Real-world data (RWD) and real-world evidence (RWE) remain promising technologies at an early adoption stage.

“When it comes to RWD/RWE, I think you’re going to see this getting traction within the large pharma space before you see this getting traction in smaller to mid-sized,” Rickenbacher said.

Harnessing RWD or RWE could require significant resources and strategic planning to determine which individuals should be responsible for implementing new processes and analyzing and interpreting data.

Similarly, blockchain is resource-intensive and requires significant planning to deploy in clinical trials. While blockchain provides considerable protection for data once it has entered the digital ledger, it has no intrinsic protection for data entry. “When it comes to clinical trials, the data input is critical,” Rickenbacher said. “A trial is only as good as its data.”

In addition, the benefits of blockchain for clinical trials remain murky compared to traditional databases. “It’s very expensive to create all the processes [required to support blockchain] at every sponsor with not a ton of examples on how to use it,” Rickenbacher said.

By contrast, there is more of an evident and concrete focus in the clinical trial space on “digitization,” which involves the intercommunication between data and processes.

“Digitization is a buzzword that is actually coming to fruition,” Rickenbacher concluded.