Examining Diversity in Digital Therapeutics Clinical Trials: Descriptive Analysis
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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 to ensure broad application to all groups. Objective: We review current 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 15 manuscripts associated with 13 DTx products. Sociodemographic information was retrieved and compared with the US population’s demographic distribution. Results: The median study size and age of participants were 252 and 43.3 years, respectively. Of the 15 studies applicable to this study, 10 (67%) reported that females made up 65% or greater of the study cohort. A total of 14 studies reported race data with Black or African American and Asian American individuals underrepresented in 9 and 11 studies, respectively. In 7 studies that reported ethnicity, Hispanics were underrepresented in all 7 studies. Furthermore, 8 studies reported education levels, with 5 studies reporting populations in which 70% or greater had at least some college education. Only 3 studies reported health insurance information, each reporting a study cohort in which 100% of members were privately insured. Conclusions: Our findings indicate opportunities for improved sociodemographic representation in DTx clinical trials, especially for underserved populations typically underrepresented in clinical trials. This review is a step in examining sociodemographic representation in DTx clinical trials to help inform the path forward for DTx development and testing.
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Diverse populations in terms of ethnicity, income and education levels, and sexual and gender minority status remain underrepresented.
“diverse populations (in terms of ethnicity, income and education levels, sexual and gender minority status, etc) remain underrepresented [172].”
From Acceptability of Digital Mental Health Interventions for Depression and Anxiety: Systematic Review (2024) · cites this paper as [172]
The Discussion (Principal Findings; page unavailable) reports underrepresentation of Asian, Black, and Hispanic participants in digital therapeutics trials, and the Results (page unavailable) show that most studies reporting education enrolled predominantly college-educated participants. The paper examines employment and insurance as socioeconomic measures, but does not establish underrepresentation by income or sexual and gender minority status; its sex data do not measure minority status. (LLM, conf=0.88)
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Acceptability of Digital Mental Health Interventions for Depression and Anxiety: Systematic Review
Lau, C. K. Y., Saad, A., Camara, B., Rahman, D., & Bolea-Alamanac, B. (2024) · Journal of Medical Internet Research · doi:10.2196/52609 · Cited by 51 · see citing works
- Authors
- Adu-Brimpong, J., Pugh, J., Darko, D. A., & Shieh, L.
- Affiliations
- Washington University in St. Louis (US)
- The University of Texas Southwestern Medical Center (US)
- Stanford Medicine (US)
- Venue
- Journal of Medical Internet Research
- Publisher
- JMIR Publications Inc.
- Published
- 2023-08-02
- Volume
- 25
- Pages
- e37447
- ISSN
- 1438-8871 (ISSN-L)
- PMC
- PMC10433021
- OpenAlex
- W4378903226
- Cited by
- 13
- References
- 22
- Citations by year
- 2025: 3 · 2024: 9 · 2023: 1
- FWCI
- 3.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Journal of Medical Internet Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- digital therapeutics, diversity in clinical trials, underrepresented groups, racial and ethnic minorities, gender representation, health insurance status, educational attainment, generalizability of trial results
- MeSH terms
- Asian, Black or African American, Educational Status, Ethnicity, Female, Humans, Male, Databases, Factual
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