JMIR Publications

ABSTRACT

Background:

Digital therapeutics (DTx) are an emerging class of software-based medical therapies helping to improve care access and delivery. As we leverage these digital health therapies broadly in clinical care, it is important to consider sociodemographic representation underlying clinical trials data.

Objective:

Here, we review sociodemographic representation in DTx clinical trials using data from the Digital Therapeutics Alliance Product Library database.

Methods:

We conducted a descriptive analysis of DTx products. We analyzed 20 manuscripts associated with 13 DTx products. Sociodemographic information was retrieved and compared with U.S. population demographics distribution.

Results:

Median study size and age of participants were n=176 and 43 years old, respectively. Of the 20 studies reviewed, 14 studies reported females as 59% or greater of the study cohort. 19 studies reported race data with Black/African American and Asian Americans underrepresented in 10 and 15 studies, respectively. In 10 studies that reported ethnicity, Hispanics were underrepresented in 9. Furthermore, 10 studies reported education levels, with 6 studies reporting populations in which 71% or more had at least some college education. Only four studies reported health insurance information, each reporting a study cohort in which 80-100% of members were privately insured.

Conclusions:

Our findings indicate opportunities for improved demographic representation in DTx clinical trials, especially for medically disadvantaged populations. This review is a step in examining sociodemographic representation in DTx clinical trials to help inform the path forward for DTx.