Growth of Digital Therapeutics Requires Collaboration Among Key Players

The rapidly expanding field of digital therapeutics would likely benefit from international collaboration among manufacturers, government regulatory agencies, and researchers, according to a study published in NPJ Digital Medicine.

“[T]he use of digital therapeutics as a general medical component is still ambiguous, and this ambiguity may be owing to a lack of consensus on a definition, in addition to insufficiencies in research and development, clinical trials, standardization of regulatory frameworks, and technological maturity,” wrote corresponding author Hangsik Shin of the University of Ulsan College of Medicine, Seoul, South Korea, and study coauthors.

The findings are based on a review and analysis of definitions, clinical trials, commercial products, and the regulatory environment surrounding digital therapeutics.

To be considered a digital therapeutic, researchers proposed the technology should be required to provide medical intervention for prevention, management, and treatment. Additionally, it should be accessible to a variety of users and proven effective through systematic clinical trials.

In addition to randomized trials, the authors advised on the importance of studies evaluating real-world outcomes. The effectiveness of digital therapeutics can vary with a user’s age, gender, culture, and cognitive ability, among other factors. Even gradual changes in a society’s cultural values can alter an intervention’s effect, they pointed out.

“This suggests that there is contemporaneity in the efficacy of digital therapeutics,” they wrote. “Consequently, digital therapeutics require periodic verification even after approval due to the change in efficacy over time, which means that digital therapeutics have an expiration date.”

The study suggests that close cooperation among researchers, manufacturers, and government will be necessary to guide the global digital therapeutic landscape into the future appropriately.

“Therefore, discussions and agreements centered on various international organizations, including those of medical devices, are required,” the authors wrote.

Reference

Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med. 2023;6(1):38. doi:10.1038/s41746-023-00777-z