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Objectives. We evaluated the racial misclassification of American Indians and Alaska Natives (AI/ANs) in cancer incidence and all-cause mortality data by Indian Health Service (IHS) Contract Health Service Delivery Area (CHSDA). Methods. We evaluated data from 3 sources: IHS-National Vital Statistics System (NVSS), IHS-National Program of Cancer Registries (NPCR)/Surveillance, Epidemiology and End Results (SEER) program, and National Longitudinal Mortality Study (NLMS). We calculated, within each data source, the sensitivity and classification ratios by sex, IHS region, and urban–rural classification by CHSDA county. Results. Sensitivity was significantly greater in CHSDA counties (IHS-NVSS: 83.6%; IHS-NPCR/SEER: 77.6%; NLMS: 68.8%) than non-CHSDA counties (IHS-NVSS: 54.8%; IHS-NPCR/SEER: 39.0%; NLMS: 28.3%). Classification ratios indicated less misclassification in CHSDA counties (IHS-NVSS: 1.20%; IHS-NPCR/SEER: 1.29%; NLMS: 1.18%) than non-CHSDA counties (IHS-NVSS: 1.82%; IHS-NPCR/SEER: 2.56%; NLMS: 1.81%). Race misclassification was less in rural counties and in regions with the greatest concentrations of AI/AN persons (Alaska, Southwest, and Northern Plains). Conclusions. Limiting presentation and analysis to CHSDA counties helped mitigate the effects of race misclassification of AI/AN persons, although a portion of the population was excluded.

•Indigenous Peoples face health inequities and barriers in clinical trial enrollment.•An Indigenous panel of advisors attended a virtual roundtable discussion.•This narrative review, supported by key publications, summarizes advisor insights.•Strategies to build effective partnerships with Indigenous communities are outlined.•Industry should invest in community-based priorities and show long-term commitment. American Indians, Alaska Natives, and Native Hawaiians (AI/AN/NH) have among the lowest representation in clinical trial participation in the United States (US) compared with other racial/ethnic groups and experience many barriers to health care access. To promote equitable and justice-centered inclusion of Indigenous Peoples in clinical trials and improve health equity, industry sponsors need to be better attuned to community-based priorities. This article summarizes perspectives including strategies to build more effective and equitable partnerships with Indigenous communities in the US and to advance access to medical care. A panel of advisors on AI/AN/NH health care assembled for a virtual roundtable discussion in March 2024. A narrative review, supported by key publications, was conducted to summarize and contextualize the discussions. AI/AN/NH face various health inequities and challenges in clinical trial enrollment, including justified distrust of medical research environments, inaccessible and unaffordable health care, and limited community engagement by the research community. Proposed methods for engagement based on advisor insights were developed to guide industry sponsors in building more effective partnerships with Indigenous communities. Engagement methods consist of several strategies such as investing in community priorities, building a long-term commitment, identifying trusted messengers, and codeveloping engagement initiatives. Current challenges regarding clinical trial diversity are impacting health outcomes among Indigenous Peoples, furthering disparities. Based on advisor engagement, establishing effective, equitable, and justice-centered partnerships between industry sponsors and Indigenous Peoples has the potential to result in community-driven priorities being recognized in clinical trials, and thus expanding benefit of medical innovation.