Digital solutions abound in healthcare and clinical research alike, with wearable devices, remote monitoring, telemedicine, and other advanced technologies in increased use in recent years. Another aspect of digital health that is seeing growing interest is digital therapeutics—the use of software-based interventions to handle diseases.
According to Allied Market Research, the worldwide DTx market could reach a value of $23.6b USD by 2030—more than six times the 2020 valuation of $3.6b USD. To gain perspective about digital therapeutics (DTx), Outsourcing-Pharma checked in with Adam Samson, senior director of clinical operations and customer success at Curebase, a software and services provider specializing in decentralized trials (he also serves as adjunct faculty at The George Washington University in the Master's in Clinical Research Administration program).
OSP: Could you please talk about the growing use of digital health tools in clinical research?
AS: Since the start of the pandemic, the clinical research industry has leaned heavily on numerous digital health technologies to support clinical trials. Consistent with other areas in healthcare, telemedicine provided the ability for clinical trial continuity during the pandemic by replacing many of the in-person interactions with remote-based contacts supported by technology.
Other tools, such as platforms that support the collection of electronic patient-reported outcomes (ePRO), have also provided the possibility for participants to do more from home—rather than traveling to a physical location. Digital endpoints, which use sensor-generated data as clinical evidence, have seen a considerable uptick, and their use has been supported by the Digital Medicine Society (DiMe) efforts to develop a standardized library. In addition, wearable digital health devices, which allow for the collection of real-world data, are supporting the use of novel digital biomarkers in clinical trials.
OSP: How did the pandemic impact use of such tools?
AS: Although all the technologies I’ve mentioned existed in some form prior to the pandemic, the interest and acceptance of these tools by the industry has increased dramatically since the start of 2020. A report by the Tufts Center for the Study of Drug Development revealed a substantial increase in the adoption of digital health solutions by top pharmaceutical companies during the pandemic, with just over half of clinical trials using some form of remote monitoring and 80% utilizing telemedicine.
OSP: Please tell us about the resources the US Food and Drug Administration (FDA) has offered for use of digital health, including the Digital Health Center of Excellence (DHCoE).
AS: The FDA has demonstrated its commitment to supporting digital health technologies recently through the publication of multiple relevant guidance documents, and the founding of the DHCoE in September 2020. The DHCoE is part of the FDA’s Center for Devices and Radiological Health (CDRH) and is tasked with aligning digital health efforts across the Agency by providing regulatory advice and support to the FDA’s regulatory review of digital health technologies.
An important point is that, although part of CDRH, the DHCoE is not responsible for making marketing authorization decisions. The DHCoE states that their customers include patients, developers, health care providers, researchers, industry, payers, other government agencies, international regulatory bodies, CDRH, and other centers within the FDA. This speaks to the ambitions and willingness of the FDA to collaborate with all stakeholders to foster innovation in the digital health sector.
OSP: Please tell us about digital therapeutics—what are they, what kinds of conditions have they been used for, and what are some of the general advantages of DTx?
AS: Per the Digital Therapeutics Alliance (DTA) definition: DTx deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders. The DTA is a non-profit association of industry stakeholders engaged in the advancement of DTx. Some of the common therapeutic areas being addressed are mental health, oncology, chronic disease management, neurology, and female health.
DTx products fill gaps within the healthcare system by providing additional options for delivering therapies to patients at scale. For example, mental health is an area where it is challenging for clinicians, given the high prevalence of related conditions, to deliver cognitive behavioral therapy (CBT) to all patients who may benefit from this treatment. To extend clinicians' capabilities, a DTx product can be developed utilizing existing CBT, which may then be deployed to a vast number of patients via an application on their smartphone.
OSP: Can you tell us about some of the challenges associated with developing and obtaining approval for DTx solutions?
AS: A significant challenge in the development and commercialization of DTx solutions is the complex regulatory landscape. From the FDA’s perspective, a digital health solution may fall under the category of a general wellness product or software as a medical device (SaMD). The former may be permitted to go directly to consumers without FDA review, while the latter generally requires FDA clearance, via 510(k) or De Novo, or premarket approval—depending on its classification as a Class I, II, or III medical devices.
Adding to this challenge is the fact that regulation of digital health products is continuing to evolve and is different across the world. Many within the industry are working to provide tools for DTx development companies to navigate this complexity. One worth mentioning is the DTA’s country-specific resource guidelines which they’ve made publicly available via their website.
OSP: Then, could you please tell us about some of the misperceptions and hesitation around DTx solutions, and how the industry might overcome them?
AS: Much of the hesitation surrounding DTx products seems to stem from misperceptions regarding their commercialization due to the various potential routes to market (e.g., payor, provider, employer, pharma, direct-to-consumer). Increasingly, DTx development companies understand the need for clinical validation of their products; however, identifying a commercialization strategy early on is crucial as clinical and economic evidence expectations and requirements by various stakeholders may vary. For example, payors may be most interested in adequately demonstrating the durability of treatment effect, while employers may be more interested in seeing a reduction in medical spending.
It is likely that some misperceptions have occurred surrounding the viability of DTx commercialization due to an inadequate assessment of the route to market and alignment with stakeholders’ requirements prior to evidence generation. HealthXL, a community intelligence platform for healthcare and digital health, has published extensively on this topic, including a January 2022 report on DTx routes to market.
OSP: Can you share any DTx success stories?
AS: Even though DTx as a treatment modality is relatively new, there is an abundance of success stories. I’ll share a recent experience from a partnership with my company, Curebase, and metaMe Health, the manufacturer of Regulora, a DTx for abdominal pain associated with irritable bowel syndrome (IBS) in adults. metaMe Health used Curebase's decentralized clinical trial (DCT) technology and services to evaluate Regulora in a randomized controlled trial.
The results of the trial showed 68% of subjects assigned to active treatment reported overall satisfaction, and 87% would recommend Regulora to someone with IBS. Late in 2021, metaMe Health received FDA 510(k) clearance for Regulora, and this DTx solution will be commercially available soon.
