Sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure, tech know-how and adaptability, while sponsors need to be willing to offer training/support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises.

Digital therapeutics — evidence-based therapeutic interventions that are driven by high-quality software programs to prevent, manage or treat a medical disorder or disease — come both in the form of independent therapeutics and adjunct products designed for use alongside drugs and other therapies. While their future is uncertain, experts see significant promise, particularly for treating mental illnesses (CenterWatch Weekly, May 1).

But sites and sponsors need to fully grasp what it takes to run DTx trials successfully. These trials can be complex, as they use highly remote components to gather data from places where the product will actually be used, such as in a patient’s home, says Cori Davis, associate director of clinical project management for Curebase, a company specializing in the execution of DTx trials.

Expect unique endpoints, high levels of remote data collection and large numbers of technology on top of the DTx product itself, which may include wearables, mobile apps and electronic patient-reported outcome (ePRO) platforms, Davis says. And because there’s so much integration and information transfer between the product and the systems that support it, it’s critical to protect the sensitive patient data being gathered.

A common complaint of sites, Davis told CenterWatch Weekly, is that there are so many different places storing different information that it’s difficult to monitor all of it on a day-to-day basis. DTx components can include “a place for eConsent information; a place where patients are submitting ePROs,” she says. “We now have to leverage electronic health records (EHR), whether that be ours or some aggregate EHR external vendor’s; things of that nature.”

Because DTx trials require more virtual meetings and fewer to no face-to-face visits, sites need appropriate communication and tech support tools as well as the drive to keep engagement going in less traditional ways. Davis notes that sites still need to maintain interaction with trial participants, such as on adherence or technical issues.

In addition to the large amounts of data they collect, the types of data gathered in DTx trials may be different from what sites are used to. These include user engagement data, user experience/satisfaction data and health economic outcomes that help sponsors determine if their DTx product is meeting patients’ needs. In DTx trials, there’s a greater emphasis on the economic impact of the investigational product that isn’t often seen in other trials, Davis says.

Recruitment approaches, too, are often different for DTx trials, which need to reach patient groups that are both capable of and interested in using these kinds of products. Prospective trial participants are often reached through digital marketing campaigns and other less traditional avenues rather than through a physician’s recommendation, for instance.

Advice for Sites

As a pivotal first step in taking on a DTx trial, sites should develop a firm understanding of the technologies that will be used. This should include not just site-facing technologies, such as eConsent, eSource and telemedicine, but also the technologies that participants themselves will be working with, including the digital therapeutic itself.

Similarly, sites interested in these trials should be sure they have the appropriate technological infrastructure established before getting into the DTx sector. That means high-speed internet, laptops and tablets to collect information and meet with participants, timely and efficient tech support to serve as a “first line of defense” (which could be provided by site staff themselves), and direct data capture capabilities.

Additionally, be aware of the complexities inherent in DTx trials and be ready to pivot accordingly. Unexpected issues may arise as a result of the technology integration and atypical endpoints in DTx trials; it’s critical that sites running these trials are flexible and prepared to adapt to changes to the trial protocol and the technologies being employed, Davis says.

She also advises that sites understand the need to monitor adherence closely in these trials and, critically, to impart the importance of this to patients.

“Ensuring accuracy and completeness can be really, really challenging,” she says. For instance, “I could give my wearable watch to my mom, and it’s still collecting data and assuming it’s me. There is a lot of education on the site side of things that should be provided to patients directly.”

Advice for Sponsors

For sponsors, it’s important to cut down on trial complexity by simplifying DTx protocols as much as possible. Sponsors could, for instance, reduce the number of procedures and study visits and simplify data collection processes to make things easier on sites. “Removing barriers for these remote scenarios is very important,” she says.

Another way sponsors can simplify these trials for sites is by working with vendors that aggregate as much information in a single place as possible. Look for all-in-one service providers and be mindful of technologies sites already have.

Sponsors should also open clear communication channels with sites and CROs, encourage and facilitate proactive action on any issues, and offer sites training and support. While it’s critical for sites to familiarize themselves with the technology at hand, sponsors also play a big part by ensuring sites have the resources they need to follow the protocol, utilize trial technologies, offer tech support and troubleshoot when things go wrong.