September 2, 2022
The virtual format is catching on but has important limitations which make it unsuitable in certain situations.
The promise of prescription digital therapeutics (DTx) is the opportunity to use the ubiquitous technology to quickly and efficiently deliver therapies to patients. Increasingly, the makers of digital therapeutics are seeking to leverage those same efficiencies to streamline clinical trials.
Earlier this summer, Swing Therapeutics announced it had hired Curavit Clinical Research to be a virtual site for the pivotal trial of Swing’s investigational fibromyalgia digital therapeutics.
Under the terms of the arrangement, Curavit will recruit, screen and enroll patients into the PROSPER-FM trial, after which Curavit will manage participants over the course of the trial’s 12 weeks. The trial involves the study of 2 digital applications, which incorporate combinations of self-management skills, mindfulness activities, symptom tracking, and disease education.
oel Morse, MBA, Curavit’s chief executive and co-founder, told Managed Healthcare Executive® that digital therapeutics are a natural fit for virtual trials.
“There are no physical logistics — no shipping, storing, chain of control, cold storage, or biohazards, plus endpoints can be captured within the digital therapeutic application itself, making DCTs [digital clinical trials] ideal for studies whether seeking regulatory approval or consumer and payer confidence,” he said.
Morse said another benefit to digital trials for digital therapies is that the products by design track the most of the relevant endpoints of the trial. As a result, he said, digital therapeutics makers can avoid the need to purchase expensive third-party software to track endpoints.
That said, the virtual format is not a fit for every scenario or indication. Without a physician or other healthcare provider directly monitoring patients in clinics, certain endpoints cannot be feasibly or reliably measured in a remote setting.
Mike Rosenbluth, Ph.D., the CEO of Swing, said the fibromyalgia trial will avoid such problems because the endpoints being studied are based upon patients’ daily experiences of the disease.
“Understanding patient outcomes in their day-to-day rather than in a provider clinic is more accurate and representative of how well they are doing,” he said.
Rosenbluth said the endpoints in PROSPER-FM are all patient-reported, which is the accepted “gold standard” for fibromyalgia studies, he said.
“Even if we conducted all in-person visits, we would still collect these outcomes remotely,” said Rosenbluth.
But Rosenbluth said one benefit of the virtual design is that patients do not have to travel to receive their therapy, which is important because the condition itself can make travel uncomfortable and difficult.
“These patients can be in pain and fatigued and it is unreasonable to ask them to take on another task when getting through their day is already hard,” he said.
One of the most important facets of any critical trial is recruitment. Studies with an insufficient number of enrollees or with enrollees who do not reflect the demographics of the real-world patient population may have limited generalizability and ultimately, limited usefulness. Rosenbluth said a virtual structure can also help in this regard.
“This approach absolutely makes it easier to get a representative sample for our study population,” he said. “This has been a real challenge in previous studies in the field.”
As for the broader potential of virtual trials, Morse said it is important that any potential virtual trial be evaluated carefully for its suitability, including “taking a cautious look at things like high morbidity patient populations, complex therapies, and significant physical and/or emotional safety concerns,”
In some cases, traditional or hybrid approaches will still be most appropriate, he said.