FormalPara Key Points

  • Clinical trials ensure that newly created medical interventions are safe and effective for general use, regardless of race, ethnicity, socioeconomic status, or social background.

  • Native Hawaiian and other Pacific Islander (NHPI) patients are underrepresented in oncology clinical trials, despite cancer disparities and willingness to participate.

  • Multiple geographic, systemic, and socioeconomic barriers prevent NHPI patients from enrolling in clinical trials.

  • NHPI representation in oncology clinical trials can be improved with intentional cultural sensitivity, community engagement, and healthcare workforce diversification.

Clinical trials are instrumental research studies that seek to ascertain the safety, efficacy, and benefit of new pharmaceuticals, surgical procedures, or other medical interventions. Phase III clinical trials are especially important in establishing whether an intervention is consistently effective across the general population [1, 2]. Greater population sampling should lead to heterogeneity in socioeconomic status, race, ethnicity, and geographic region, with data informing the clinical application of new treatments to specific subpopulations [1, 2]. Although race is a social construct, certain ethnic groups and ancestral identifiers may share common genetic patterns, disease burdens, or social circumstances that influence their responses to tested therapies [1, 2]. Inclusivity in clinical trials, therefore, has the potential to promote generalizability for newly developed treatments.

Current Representation Issues

Despite efforts to improve racial inclusivity, clinical trial diversity in the United States remains unsatisfactory, with only 44% of clinical trials reporting participants’ race/ethnicity [3]. While disparities in Black and Hispanic representation have been highlighted, Native Hawaiian and Pacific Islander (NHPI) representation is under-acknowledged and underreported (see Gimmen et al. in this volume). NHPI representation comprises only 8% of clinical trials (compared to 70% White, 59% Black, 54% Asian, and 14% American Indian/Alaska Native) [4], making NHPI among the most understudied groups in clinical trials, despite high rates of cancer incidence and mortality in this population.

Barriers to Clinical Trial Participation

Several factors influence clinical trial participation among NHPI communities (Fig. 72.1).

Fig. 72.1
4 tables for the barriers to N H P I participation. They list the perceptions of research, socioeconomic factors, geography and infrastructure, and unconscious bias and research design.

Barriers to NHPI participation in clinical trials

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Perceptions of Research

Studies show that members of minoritized groups are willing to participate in research if offered the opportunity [1]. However, distrust of the medical system is common within the NHPI community, derived from a history of colonial trauma and resource and labor exploitation [5]. Many NHPI patients have had negative experiences in healthcare settings and perceive them as places of sickness and suffering, rather than of healing and comfort [5, 6]. For example, Indigenous Chuuk Pacific Islanders report cultural disconnection and discrimination when interacting with Western doctors, exacerbated by a lack of NHPI healthcare professionals [5, 7, 8]. A lack of cross-cultural humility stymies the potential to create strong foundations to build patient–physician relationships. Differences in cultural expectations and norms also create barriers [1, 6]. A study of Native Hawaiian men found that underutilization of healthcare and avoidance of discussing health topics is due in part to a desire to not appear weak or be a burden [1, 6].

Despite these negative perceptions of Western healthcare, many NHPI patients value their overall health and wellbeing [5, 6]. Native Hawaiian values, including pono (harmony/righteousness), are embedded in community, evidenced by the prevalence of Indigenous healers and health teachers. Research has found that NHPI patients are willing to participate in clinical research when provided with complete information. “Unwillingness” to participate is not a limiting factor; rather, an accumulation of structural barriers, many embedded within the research process itself, make it difficult for NHPI individuals to participate in clinical trials [1].

Geographic and Structural Barriers

While there is a significant NHPI population in the continental United States, most of the population remains on remote and isolated islands across the Pacific, with some regions, such as the Federal States of Micronesia and the Commonwealth of the Northern Mariana Islands, composed of several smaller island communities, further subdividing the populations [5]. Uneven population distribution has led to disparate healthcare access across Oceania. While Hawaiʻi has 28 hospitals, the 28 populated areas of the Marshall Islands rely on two hospitals—in Majuro and Ebeye [5]. Access to subspecialty care is often challenging. Hawaiʻi—the most urbanized of the Pacific Islands—is home to only one American College of Radiology–accredited radiation oncology center that services the entire state and the United States Affiliated Pacific Islands (USAPI).

Distance and travel times to clinical sites are major barriers to recruitment, discouraging enrollment and adherence [1]. These are even more extreme for remote islands separated by vast distances of ocean. For the Indigenous people of Yap in Micronesia, the nearest major hospital, on Guåhan, is only accessible by limited boat or plane options, and patients are unlikely to travel frequently for check-ups and treatment [5]. Even in Hawaiʻi, with its major airports, travel duration to clinical trial sites is both substantial and financially and environmentally unsustainable. Once on island, ground transportation can be a further challenge, due to a lack of paved roads or reliable vehicles [5]. Thus, incentivizing patients to participate in clinical trials, even those with potential life-saving benefits, can be difficult throughout the Pacific.

Researchers are even less likely to conduct clinical trials outside of Hawaiʻi. In a study of 83 clinical trials, only 6% were conducted in the USAPI and the rest in Hawaiʻi or the continental United States, possibly owing to the lack of infrastructure and funding to conduct clinical trials in island hospitals [5, 9, 10]. Lack of community outreach and/or lack of general researcher interest are likely other contributing factors, as even telehealth and focus group studies are not widely conducted [1, 5, 9]. The need for oncology care remains strong throughout the Pacific Islands, particularly by healthcare professionals deeply rooted in these islands.

Socioeconomic Barriers

An estimated 50% of clinical trial participants have high socioeconomic status [1]. People from lower socioeconomic backgrounds are likely to face greater challenges, such as multiple jobs, constricting work hours, limited ability to take time off, greater travel distances to hospitals, child and family care, and education, all of which are opportunity costs that conflict with clinical trial participation.

The NHPI population is among the most impoverished in the United States, with 15% living at the poverty line and 6% unemployed [10]. Many NHPI patients are food and housing insecure, and the population experiences an extensive chronic disease burden [5, 10]. The opportunity cost of attending time-consuming clinical trials, therefore, deters eligible NHPI individuals from participating in potentially beneficial treatments.

Unconscious Bias in Research Design

Research design can be unconsciously biased, perpetuating multiple-level inaccessibility. Site selection and time expectations exclude large numbers of eligible NHPI individuals who live in rural or remote areas, lack suitable transportation, have constraining work hours, or have competing familial responsibilities [1, 5, 9].

Modern research recruitment advertising methods (mass media, the internet, television, etc.) may potentially miss eligible NHPI candidates, owing to a lack of phone and internet access in some regions. Furthermore, given the role of trust in Indigenous communities, lack of investment in word-of-mouth marketing, engagement in community norms, or meeting with community leaders further isolates eligible participants [1, 5, 9].

A further barrier is the lack of research materials in Indigenous languages or simple English. Although English is commonly spoken in Hawaiʻi and Guåhan, native dialects are spoken elsewhere, making understanding of consent forms difficult if they are poorly or simply not translated [1, 5, 9].

Restrictive patient inclusion and exclusion criteria, generally aimed at recruiting “healthier patients” are also a barrier. The NHPI community experiences a high comorbidity and disease burden, combined with a lack of early diagnosis (due to limited preventative services), resulting in more severe end-stage diseases, thus excluding many NHPI patients from trial participation [1, 5].

Finally, NHPI participants are often aggregated with Asian participants during data analysis (see Gimmen et al. in this volume). Historically, this helped to increase the political leverage of both groups; however, in the medical research setting, it masks disparities between them, leading to false and overgeneralized conclusions concerning the health of NHPI communities [5, 9].

Increasing NHPI Representation in Clinical Trials

NHPI individuals, community organizations, and NHPI allies have invested significant effort in improving research participation, as shown in these examples.

  • The Ka-Holo trial investigating the therapeutic value of the traditional Hawaiian dance, hula, in treating hypertension, found that the intervention significantly improved blood pressure [11]. This trial should serve as a framework for future studies, demonstrating the integration of clinical science through a culturally relevant lens, led by Indigenous researchers, and aimed at creating health interventions applicable to a particular population [11].

  • No Ke Ola Pono o Nā Kāne combined the traditional practice of hale mua (men’s house) with cancer and hypertension prevention education to create a culturally relevant space for men to talk about health and foster holistic wellbeing [12].

  • Community-based organizations such as ʻImi Hale spread awareness of Native Hawaiian health issues, educate patients about cancer and clinical trials, engage with research leaders, secure funding, and set norms on how research should be conducted within communities [13]. Notably, they have created pathway programs to train young, prospective Indigenous researchers in proper conduct and in gaining exposure to NHPI health issues.

  • A Center for Pacific Islander Health has been established at the University of Arkansas to conduct research on the state’s growing Marshallese population, emphasizing intercultural communication [14].

While great strides have been taken particularly for Native Hawaiian health, programs that serve other Pacific Islanders are urgently needed.

Cultural Competency and Respect

The future of NHPI-inclusive oncology clinical trials depends on the factors outlined in Fig. 72.2.

Fig. 72.2
An illustration lists the keys to promoting sustainable clinical research. They are as follows, invest in community leaders, integrate cultural traditions into research programming, develop intentionally designed data collection systems, and support pipeline programs.

Keys to promoting sustainable clinical research inclusive of NHPI populations

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To mitigate NHPI mistrust of the medical community, researchers should recruit influential community leaders and leverage established local networks to contribute to study design and oversight, ensuring that communication methods and subject-recruitment practices are culturally informed. Full commitment to building rapport within the community by honoring cultural norms, such as employing oral tradition formats in focus groups or hosting communal events, such as meals or discussions, can nurture long-lasting relationships of trust that support research engagement [10]. Ultimately, bidirectional learning between clinical researchers and the NHPI community is essential.

Intentional research design can lower barriers to participation by offering more flexible data collection methods. Researchers can increase accessibility by collecting data in community or faith centers, offering telemedicine collection in areas with internet access, and providing free transportation to data collection sites [1, 9]. Similarly, investing in the recruitment and training of local investigators empowers communities to have greater research conduct oversight and creates a more approachable presence on the ground. Local investigators, possessing the Indigenous context to retain idiomatic or nonverbal information often lost in verbatim translation, can monitor medication regimens, provide guidance, and collect data from patients at home [9].

These suggestions rely on sufficient research funding, with resources available for community investment. We propose supporting initiatives to restructure clinical trial funding that prioritizes the recruitment of diverse subject pools [1].

  • Convenience sampling, which targets one population over another due to ease of access, leads to selection bias and should be avoided. We advocate for proactive engagement with Indigenous communities by financially empowering key community champions and leaders, thereby enhancing access to and awareness of available opportunities [15].

  • To ensure that diversity and equity remain clinical research priorities, we support pathway programs such as ʻImi Hale that offer Indigenous youth exposure to the STEM disciplines and provide science and leadership mentorship. While the recent 2023 United States Supreme Court decision on affirmative action has overturned historical precedents in education, it serves as a reminder that the values of diversity and inclusion should not be taken for granted. In this context, allies should make every effort to advocate for the safeguarding of diversity in education and research.

Embracing cultural competency, involving community leaders, and providing flexible data collection methods can foster inclusivity. Prioritizing diverse NHPI populations and supporting NHPI researchers will pave the way for a more equitable healthcare system.

KT was supported by the Stanford Cancer Institute through the Stanford Cancer Institute’s Women’s Cancer Center Innovation Award and Fellowship Award and by the American Society for Clinical Oncology Dr Judith and Alan Kaur Endowed Young Investigator Award.