Abstract
PURPOSE: Ensuring diverse representation in atopic dermatitis (AD) clinical trials is crucial for assessing the effectiveness and safety of interventions across different populations. This study aimed to quantify and evaluate the demographic diversity of participants in AD clinical trials conducted in the United States.
DESIGN AND METHODS: We conducted a systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligible studies were original clinical trials evaluating interventions for AD in the United States. Data extraction was performed using a standardized Google form to capture trial characteristics and participant demographics (sex, age, race, ethnicity). Participant diversity was assessed using the Clinical Trial Diversity Rating (CDR) framework. We calculated the Participant to Disease Prevalent Ratio (PDRR) and presented it as a point estimate in the meta-analysis, with confidence intervals derived through logarithmic transformation.
RESULTS: Out of 279 records screened, eight studies were included in the systematic review and meta-analysis. Among the six studies reporting Black participant inclusion, three showed overrepresentation (50% and two showed underrepresentation (33.3%). Hispanic/Latinx participants were underrepresented in four of the six studies that reported race and ethnicity demographics (66.7%). Reporting on Asian demographics was inconsistent, with only three of the eight trials (37.5%) providing this information. Only one study included participants over 65 years old (12.5%), while five studies focused on pediatric populations (62.5%).
DISCUSSION AND CONCLUSION: AD clinical trials in the United States showed variable inclusion of participants across racial and ethnic groups, with a significant lack of representation among older adults. This inadequate diversity in clinical trials may limit the generalizability and applicability of their findings to broader populations.
DESIGN AND METHODS: We conducted a systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligible studies were original clinical trials evaluating interventions for AD in the United States. Data extraction was performed using a standardized Google form to capture trial characteristics and participant demographics (sex, age, race, ethnicity). Participant diversity was assessed using the Clinical Trial Diversity Rating (CDR) framework. We calculated the Participant to Disease Prevalent Ratio (PDRR) and presented it as a point estimate in the meta-analysis, with confidence intervals derived through logarithmic transformation.
RESULTS: Out of 279 records screened, eight studies were included in the systematic review and meta-analysis. Among the six studies reporting Black participant inclusion, three showed overrepresentation (50% and two showed underrepresentation (33.3%). Hispanic/Latinx participants were underrepresented in four of the six studies that reported race and ethnicity demographics (66.7%). Reporting on Asian demographics was inconsistent, with only three of the eight trials (37.5%) providing this information. Only one study included participants over 65 years old (12.5%), while five studies focused on pediatric populations (62.5%).
DISCUSSION AND CONCLUSION: AD clinical trials in the United States showed variable inclusion of participants across racial and ethnic groups, with a significant lack of representation among older adults. This inadequate diversity in clinical trials may limit the generalizability and applicability of their findings to broader populations.
Original language | American English |
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Pages | 26 |
State | Published - 13 Sep 2024 |
Event | 2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health - Oklahoma State University College of Osteopathic Medicine at the Cherokee Nation, Tahlequah, United States Duration: 13 Sep 2024 → 13 Sep 2024 |
Conference
Conference | 2024 Symposium on Tribal and Rural Innovations in Disparities and Equity for Health |
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Abbreviated title | STRIDE 2024 |
Country/Territory | United States |
City | Tahlequah |
Period | 13/09/24 → 13/09/24 |