Digital therapeutics are poised to revolutionize the healthcare industry. From enhancing current medical treatments to addressing the previously unmet needs of patients, these innovative technologies implement common best practices for design, clinical validation, usability, and security to ensure they meet the rigorous standards of regulatory bodies and the expectations of healthcare professionals and patients.
This new category of medicine is held to the same high standards as all currently existing and in-development products. Because of their integrity, the applicability of digital therapeutics products to patient care—and the associated accessibility and personalization for individualized patients—is constantly expanding, with many new uses on the horizon.
Defining Digital Therapeutics
The Digital Therapeutics Alliance (DTA) is a nonprofit founded in 2017 with the goal of bringing together industry leaders and stakeholders to advance digital therapeutics through thought leadership and evidence-based research. DTA defines digital therapeutics as products that deliver software-driven, evidence-based, therapeutic inventions to patients to help prevent, manage, or treat medical conditions.
With wide utility and clinical applicability, digital therapeutics have proven themselves particularly useful in improving patient outcomes. Their first entrance into the market was in 1995, when a Boston physician created a research program to develop and apply technology that would allow for care delivery outside of traditional clinical settings. The physician—Joseph Kvedar, currently a professor of dermatology at Harvard Medical School and a practitioner at Massachusetts General Hospital—wanted to surpass the limitations of healthcare delivery while utilizing fewer resources to provide patient care.
One particular benefit of digital therapeutics is their ability to deliver cost-effective care—compared with traditional therapies—that require less direct clinician intervention. This benefit is especially valuable in conditions otherwise poorly addressed by the healthcare system, including some chronic conditions or neurological disorders.
Digital Therapeutics in Clinical Settings
For clinical researchers, digital therapeutics represent an opportunity to reshape the future of clinical trials. Clinical trials are expensive, and the approval process is often long and arduous. However, some believe that the regulatory process for digital therapeutics may be quicker—giving sponsors a way to get more products to market faster. The speed of developing technology is outpacing the way trials are currently run, so some sponsors may need to go back to the drawing board.
As with outcomes in the exam room, patient outcomes in digital therapeutics clinical trials are improving outcomes every day—especially because digital therapeutics can generally collect real-time data, placing information directly at the fingertips of investigators.
In September 2020, three PRA experts discussed the role that digital therapeutics play in clinical trials, including associated challenges and innovations. Scott Schliebner, Senior Vice President, Scientific Affairs and Digital Therapeutics Lead; Maria Harrison, Vice President, Real World Solutions; and Robert Bauer, Director of Operations, Real World Solutions, indicated that the shift away from the evaluation of a traditional drug or medical device toward the evaluation of software as a device or therapy changes everything about how clinical trials are approached. The space is novel for regulators, sponsors, and payers alike.
During the trial design process, sponsors should answer a few key questions:
- How will the product reach patients?
- How can stakeholders be educated?
- How will patients use this intervention in a real-world setting?
From there, sponsors can address the broader regulatory issues that remain undefined through early consultation and endpoint selection.
It can also be difficult to prove efficacy since patients interact with digital therapeutics differently than they would interact with traditional treatments in a conventional study setting. These digital therapeutics trials take place in a patient’s daily life and in their own environment. Sponsors need to figure out how to manage these conditions, rigorously collect the necessary data, and evaluate the efficacy within these sometimes novel constraints.
Unfortunately for sponsors, the primary challenge of digital therapeutics is the generation of clinical safety and efficacy evidence, which is still sparse. Digital endpoints can be utilized for these trials, but currently having no gold standard makes the validation of these digital endpoints and diagnostics a major challenge. There’s also limited experience and evidence for how digital endpoints can be used for primary outcome measurements in randomized clinical trials, and trial design itself may need to be rethought.
Real-World Case: Medication Adherence and Other Benefits
Globally, between one quarter and one half of people do not take medications as prescribed. Within the United States, that practice is associated with 125,000 deaths and costs of more than $289 billion USD per year. When traditional pharmaceutical therapies are combined with digital therapeutics—from digital approaches for behavioral modification to regular patient engagement through apps and platforms—medication adherence can be significantly increased.
Another, perhaps more controversial, option for digital therapeutics-based medication adherence is through the development of pills that themselves report to providers when they are taken. One iteration of this incorporates ingestible sensors in pills. The pills are swallowed, and then they generate electrical signals detected through a patch worn on the patient’s skin. Digital records are sent to a smartphone app, which are then shared with the patient’s healthcare prover.
The first of these pills was approved by the US Food and Drug Administration in 2017. However, public concerns about what the New York Times called “biomedical Big Brother” show that public trust in these types of digital therapeutics isn’t exactly high.
For less controversial digital therapeutics—options that help patients manage conditions and medication scheduling or offer alternative treatment strategies, digital care plans, and artificial intelligence-powered services—PRA experts believe that the future is bright.
Greg Licholai, MD, SVP, and Chief Medical Information Officer, Therapeutic Experience at PRA Health Sciences, pointed out that digital therapeutics offer more distributional benefits compared with other healthcare services and are poised to aid an overburdened healthcare system. These digital therapeutics are also more scalable than traditional medical services, and they can reduce gaps in patient care—an important aspect of improving patient outcomes.
Digital therapeutics may also represent an avenue for care access to patients who are traditionally underserved: those who live in rural areas with limited healthcare options, those without insurance or those from specific socioeconomic backgrounds, and those who are dealing with behavioral health issues or fighting addiction. For patients with substance use disorder, in particular, the 2017 FDA approval of the first prescription digital therapeutic—a mobile application used in conjunction with alcohol, cocaine, marijuana, and stimulant use disorders—launched a new treatment paradigm.
Meeting unmet patient needs is one of the best ways digital therapeutics can gain a mainstream foothold in the healthcare industry. Sponsors who can close these gaps—whether due to disease type or patient sociodemographic factors—will be leaders in the future of the digital therapeutics industry.
To continue and encourage this growth, the DTA is working on multiple initiatives with the goal of global advancement of digital therapeutics. First on the list is establishing a formal definition of digital therapeutics, as well as core principles for these products. DTA is also working toward engaging with clinicians and other decision-makers to encourage the adoption of digital therapeutics into care, which will translate directly into patient- and population-level improvements in outcomes. Policy-level changes are also on the agenda, including addressing and updating regulatory frameworks, collaborating with stakeholders across the industry to optimize impact, and educate users about digital therapeutics and their value.
Digital therapeutics are clearly here to stay because they provide vast benefits to sponsors, clinical researchers, and patients.
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