This requires a new process for approving products that could include a pre-certification process with support from the DHCoE and then submission of clinical evidence to gain FDA approval or clearance. The challenge here is that even if a DTx company wins regulatory approval or clearance, there is no guarantee that payers are going to provide reimbursement. They may conclude that there is insufficient evidence to support the coverage of a particular product.

To accelerate the adoption and integration of DTx into healthcare, the non-profit Digital Therapeutics Alliance (DTA) was formed in 2017 by DTx technology manufacturers from around the world. Since its inception, DTA has grown to more than 70 members. Among those supporting DTA is Curebase, which recently announced a research and education partnership designed to help DTx organizations conduct effective clinical trials.

How do you generate clinical evidence for your product? What clinical evidence do you need for your product? And how do you design clinical trials or other research to generate that clinical evidence? These are questions our efforts with DTA hopes to answer.

There are no cookie-cutter solutions or processes because different stakeholders often want different data. While regulators may want to see a lot of safety data before granting approval or clearance of a DTx product, payers may be more interested in data on treatment durability. For example, they might want to know whether a 12-week cognitive behavioral therapy app is going to help patients after a year or two.

Shifting mindsets
If anything, digital therapeutics manufacturers are being held to almost a higher standard than some of the drug companies because there isn't standardization around what kind of clinical evidence applicants must provide to have their products accepted by both regulators and payers. This is part of the reason why some DTx companies are trying to go direct to patients or working with employers to provide DTx treatments to employees. These routes, however, present their own challenges.

While the list of DTx treatments approved by the FDA and other regulatory agencies around the world continues to grow, much work remains to establish industry expectations and educate regulators, DTx vendors, payers and providers. It’s still hard for many people to grasp that software itself can be the treatment.

Shifting mindsets isn’t easy. Persuading regulators, payers, providers and patients about the effectiveness of DTx will take time and evidence in the form of studies that include real-world data and results. Fortunately, that evidence is growing daily.

About the author: For more than a decade, Adam Samson has helped to conduct clinical trials across multiple therapeutic areas within academia, sites, CROs, pharma, and tech. He currently serves as the senior director of clinical operations and customer success at Curebase, a software and services provider purpose-built for decentralized clinical trials (DCT). Samson also serves as adjunct faculty at The George Washington University in the Master's in Clinical Research Administration program.

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