The fast-evolving world of digital therapeutics offers the promise of lowering barriers to accessing health care, but the companies behind these software-based tools face an uphill battle in convincing clinicians and insurers that their products can complement traditional medicine. That debate has largely focused on the quality of evidence backing these prescription digital therapies.
A new paper published on Monday in Health Affairs looked at 117 pre-market and post-market clinical trials supporting 20 prescription digital therapeutics cleared by the Food and Drug Administration that were on the market as of November 2022. The authors found that most studies lacked information about the race and ethnicity of trial participants, excluded older participants, and often required the participants to be proficient in English.
“The exclusion of older adults, the lack of data on race, the lack of data on ethnicity — if you can’t measure it, how are you going to fix it?” said Sanket Dhruva, an assistant professor of medicine at the University of California, San Francisco, and the primary investigator of the study.