TY  - JOUR
AU  - Adu-Brimpong, Joel
AU  - Pugh, Jennifer
AU  - Darko, David Agyen
AU  - Shieh, Lisa
PY  - 2023
DA  - 2023/8/2
TI  - Examining Diversity in Digital Therapeutics Clinical Trials: Descriptive Analysis
JO  - J Med Internet Res
SP  - e37447
VL  - 25
KW  - digital therapeutics, DTx
KW  - clinical trials, health informatics
KW  - digital health
KW  - digital medicine
KW  - DTx clinical trials
KW  - health equity
KW  - digital therapy
KW  - demographic
KW  - sociodemographic
KW  - representation
KW  - software
KW  - telehealth
KW  - telemedicine
AB  - 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. 
SN  - 1438-8871
UR  - https://www.jmir.org/2023/1/e37447
UR  - https://doi.org/10.2196/37447
UR  - http://www.ncbi.nlm.nih.gov/pubmed/37531157
DO  - 10.2196/37447
ID  - info:doi/10.2196/37447
ER  -