Abstract
Objective: This study aimed to assess the inclusion of diversity for race/ethnicity, sex, and age in clinical trials of osteoporosis in the U.S. from 2017-2023. Background: Osteoporosis is characterized by decreased bone density and an increased fracture risk. Despite the disease affecting diverse populations within the U.S., clinical trials often include an overrepresentation of white participants, leading to non-generalizable results needed to effectively treat the entire disease population. This study aimed to highlight areas where clinical trial diversity inclusion can be improved so that we may have a more comprehensive understanding of osteoporosis interventions.
Methods: We performed a comprehensive search using MEDLINE (PubMed) and Embase (Elsevier) to identify osteoporosis clinical trials published between January 1, 2017, and December 31, 2023. Inclusion criteria was met if the trial focused on osteoporosis interventions within the U.S. during this time period. Studies were evaluated following the Clinical Diversity Rating framework, which determines the participation-to-disease representation ratio for select demographics within a study and assigns a rating (poor, fair, or good) based on the relationship of osteoporosis clinical trial participants compared to U.S. prevalence statistics.
Results: Among the 7 trials included, one study received a ‘fair’ rating for race/ethnicity representation (n = 1, 14.3%), while the remaining studies received a ‘poor’ rating (n = 6, 85.7%). None of the studies received a ‘good’ rating for race/ethnicity representation. The meta-analysis of PDRR values suggests a general theme of overrepresentation of white participants and an underrepresentation of Asian, Black, and Hispanic participants.
Conclusion: Our findings highlight the need for inclusion of diverse participants within osteoporosis clinical trials. The lack of diverse populations in U.S. clinical trials threatens the effectiveness and generalizability of osteoporotic treatments. Therefore, clinical research must prioritize diversity to ensure equitable healthcare outcomes and informed decision-making.
Methods: We performed a comprehensive search using MEDLINE (PubMed) and Embase (Elsevier) to identify osteoporosis clinical trials published between January 1, 2017, and December 31, 2023. Inclusion criteria was met if the trial focused on osteoporosis interventions within the U.S. during this time period. Studies were evaluated following the Clinical Diversity Rating framework, which determines the participation-to-disease representation ratio for select demographics within a study and assigns a rating (poor, fair, or good) based on the relationship of osteoporosis clinical trial participants compared to U.S. prevalence statistics.
Results: Among the 7 trials included, one study received a ‘fair’ rating for race/ethnicity representation (n = 1, 14.3%), while the remaining studies received a ‘poor’ rating (n = 6, 85.7%). None of the studies received a ‘good’ rating for race/ethnicity representation. The meta-analysis of PDRR values suggests a general theme of overrepresentation of white participants and an underrepresentation of Asian, Black, and Hispanic participants.
Conclusion: Our findings highlight the need for inclusion of diverse participants within osteoporosis clinical trials. The lack of diverse populations in U.S. clinical trials threatens the effectiveness and generalizability of osteoporotic treatments. Therefore, clinical research must prioritize diversity to ensure equitable healthcare outcomes and informed decision-making.
| Original language | American English |
|---|---|
| Pages | 53 |
| State | Published - 13 Sep 2024 |
| Event | Symposium on Tribal and Rural Innovation in Disparities and Equity for Health - Tahlequah, United States Duration: 13 Sep 2024 → 13 Sep 2024 |
Conference
| Conference | Symposium on Tribal and Rural Innovation in Disparities and Equity for Health |
|---|---|
| Country/Territory | United States |
| City | Tahlequah |
| Period | 13/09/24 → 13/09/24 |