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ImportanceHaving diverse participants in clinical trials ensures new drug products work well across different demographic groups, making health care safer and more effective for everyone. Information on the extent of Native Hawaiian and Pacific Islander participation in clinical trials is limited.ObjectiveTo examine representation of Native Hawaiian and Pacific Islanders in clinical trials leading to the first US Food and Drug Administration (FDA) approvals for the 10 drug products with the top worldwide sales forecasts in 2024.Design, Setting, and ParticipantsCross-sectional secondary analysis of existing data from clinical trials that took place from 2006 to 2021 in the US. All clinical trials that were included in the FDA first approval application for the 10 drug products were evaluated in this study. Data were analyzed from February to August 2024.ExposureParticipation in a clinical drug trial.Main Outcomes and MeasuresComparison of the proportion of Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts in 2024 to the Native Hawaiian and Pacific Islander population proportion.ResultsIn this cross-sectional study of 139 062 individuals, Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts was either unknown or low. For 6 of the 10 drug products (60%), the number of Native Hawaiian and Pacific Islander participants was not documented. All trials that reported Native Hawaiian and Pacific Islander participation had fewer Native Hawaiian and Pacific Islander participants than would be expected based on their US population proportion, with 2 of the differences being statistically significant. Of the trials that disaggregated Native Hawaiian and Pacific Islander participants from other racial groups, the number of Native Hawaiian and Pacific Islander participants was 8 for risankizumab-rzaa (0.38% of participants vs 0.49% of the population; percentage point difference, −0.11%; 95% CI, −0.37% to −0.15%), 7 for bictegravir/emtricitabine/tenofovir alafenamide (0.38% of participants vs 0.49% of the population; percentage point difference, −0.10%; 95% CI, −0.39% to 0.18%), 27 for 4vHPV/9vHPV (0.15% of participants vs 0.46% of the population; percentage point difference, −0.31%; 95% CI, −0.37% to −0.26%), and 90 for BNT162B2 COVID-19 vaccine (0.20% of participants vs 0.52% of the population; percentage point difference, −0.32; 95% CI, −0.36% to −0.27%).Conclusions and RelevanceIn this cross-sectional study, limited documentation and participation of Native Hawaiian and Pacific Islander individuals in clinical trials for drug products with top sales forecasts was found. This is especially concerning because Native Hawaiian and Pacific Islander individuals have a higher risk than other racial groups for type 2 diabetes, cancer, and several other conditions the products examined in this study treat. Given the importance of enrolling Native Hawaiian and Pacific Islander participants in clinical trials, sites should be established in key geographic regions, such as Hawai‘i, and postmarket studies should be conducted within Native Hawaiian and Pacific Islander populations.
ImportanceHaving diverse participants in clinical trials ensures new drug products work well across different demographic groups, making health care safer and more effective for everyone. Information on the extent of Native Hawaiian and Pacific Islander participation in clinical trials is limited.ObjectiveTo examine representation of Native Hawaiian and Pacific Islanders in clinical trials leading to the first US Food and Drug Administration (FDA) approvals for the 10 drug products with the top worldwide sales forecasts in 2024.Design, Setting, and ParticipantsCross-sectional secondary analysis of existing data from clinical trials that took place from 2006 to 2021 in the US. All clinical trials that were included in the FDA first approval application for the 10 drug products were evaluated in this study. Data were analyzed from February to August 2024.ExposureParticipation in a clinical drug trial.Main Outcomes and MeasuresComparison of the proportion of Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts in 2024 to the Native Hawaiian and Pacific Islander population proportion.ResultsIn this cross-sectional study of 139 062 individuals, Native Hawaiian and Pacific Islander participation in clinical trials for the 10 drug products with top sales forecasts was either unknown or low. For 6 of the 10 drug products (60%), the number of Native Hawaiian and Pacific Islander participants was not documented. All trials that reported Native Hawaiian and Pacific Islander participation had fewer Native Hawaiian and Pacific Islander participants than would be expected based on their US population proportion, with 2 of the differences being statistically significant. Of the trials that disaggregated Native Hawaiian and Pacific Islander participants from other racial groups, the number of Native Hawaiian and Pacific Islander participants was 8 for risankizumab-rzaa (0.38% of participants vs 0.49% of the population; percentage point difference, −0.11%; 95% CI, −0.37% to −0.15%), 7 for bictegravir/emtricitabine/tenofovir alafenamide (0.38% of participants vs 0.49% of the population; percentage point difference, −0.10%; 95% CI, −0.39% to 0.18%), 27 for 4vHPV/9vHPV (0.15% of participants vs 0.46% of the population; percentage point difference, −0.31%; 95% CI, −0.37% to −0.26%), and 90 for BNT162B2 COVID-19 vaccine (0.20% of participants vs 0.52% of the population; percentage point difference, −0.32; 95% CI, −0.36% to −0.27%).Conclusions and RelevanceIn this cross-sectional study, limited documentation and participation of Native Hawaiian and Pacific Islander individuals in clinical trials for drug products with top sales forecasts was found. This is especially concerning because Native Hawaiian and Pacific Islander individuals have a higher risk than other racial groups for type 2 diabetes, cancer, and several other conditions the products examined in this study treat. Given the importance of enrolling Native Hawaiian and Pacific Islander participants in clinical trials, sites should be established in key geographic regions, such as Hawai‘i, and postmarket studies should be conducted within Native Hawaiian and Pacific Islander populations.
BackgroundNative Hawaiian and Pacific Islander (NHPI) women experience significant disparities in breast cancer treatment and outcomes, including lower rates of postmastectomy reconstruction, higher refusal rates of radiation therapy, and delays in surgical care. These disparities contribute to poorer survival and increased complications compared to other racial/ethnic groups. This systematic review and meta‐analysis aim to quantify these disparities and assess their impact on breast cancer outcomes in NHPI women.MethodsA comprehensive search of PubMed, Scopus, and Embase databases was conducted to identify studies reporting on breast cancer surgery, reconstruction, radiation therapy refusal, and surgical delays for NHPI women. Thirteen studies, encompassing a total of 5 546 918 patients, were included, and meta‐analyses were performed to pool odds ratios (OR) and hazard ratios (HR) for key outcomes using random‐effects models. Heterogeneity was assessed using I² statistics. Thematic analysis was also conducted to explore cultural and structural factors influencing treatment disparities.ResultsNHPI women had significantly lower odds of receiving postmastectomy reconstruction compared to non‐Hispanic White women (pooled OR = 2.02, 95% confidence interval [CI]: 1.96–2.08, I² = 99%). Delays in surgical care were more frequent, with NHPI women being 4.51 times more likely to experience delays (OR = 4.51, 95% CI: 3.82–5.32, I² = 99%). Radiation therapy refusal was notably higher, with a pooled hazard ratio of 3.28 (95% CI: 2.99–3.58, I² = 77%) indicating that NHPI women who refused radiation therapy had more than three times the risk of mortality compared to those who accepted it. Thematic analysis revealed that geographic isolation, limited access to specialized care, and cultural perceptions surrounding cancer treatments, including fear of radiation due to historical trauma, contributed significantly to treatment disparities.ConclusionsNative Hawaiian and Pacific Islander women face considerable barriers to receiving equitable breast cancer treatment and reconstruction, resulting in worse outcomes compared to other racial/ethnic groups. Efforts to address these disparities must focus on improving access to care, reducing treatment delays, and implementing culturally sensitive interventions. Targeted policies and healthcare system improvements, especially in geographically isolated areas, are critical to improving survival and treatment outcomes for NHPI women.
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