A recent study published in JAMA Oncology has revealed a significant underrepresentation of Native Hawaiians and Pacific Islanders in clinical trials for several top-selling drugs. This disparity raises concerns about equitable access to innovative therapies and the consideration of unique healthcare needs within this population.
The study examined data from 139,062 patients participating in clinical trials for ten drugs with high sales forecasts, including pembrolizumab (Keytruda), semaglutide, dupilumab (Dupixent), apixaban (Eliquis), bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy), daratumumab (Darzalex), nivolumab (Opdivo), BNT162B2 COVID-19 vaccine, 4vHPV/9vHPV, and risankizumab-rzaa (Skyrizi). Researchers found that 60% of these trials had no documented participation from Native Hawaiians and Pacific Islanders, despite this group representing approximately 0.5% of the U.S. population (1.7 million people, according to 2021 US Census Data).
For the 40% of trials where participation was documented, the representation of Native Hawaiians and Pacific Islanders was lower than their proportion in the U.S. population. Notably, two trials showed statistically significant, albeit limited, representation: the 4vHPV/9vHPV vaccine trial (0.15% participation vs. 0.46% population share) and the BNT162B2 COVID-19 vaccine trial (0.20% participation vs. 0.52% population share).
"Ensuring Native Hawaiian and Pacific Islander representation in clinical trials for US marketing authorization approvals of drug products is essential so that Native Hawaiian and Pacific Islander individuals have access to innovative new therapies and so their unique needs are addressed in the development and evaluation of high-impact treatments," the study authors stated.
The researchers also noted the common practice of grouping Native Hawaiians and Pacific Islanders within the broader "Asian" category, which obscures their specific representation and inflates the overall percentage of Asian participants. This aggregation can mask disparities and hinder the development of targeted interventions.
Addressing the Disparity
To improve representation, the study authors suggest several strategies, including establishing recruitment sites in Hawaii, creating referral networks to engage Native Hawaiian and Pacific Islander communities, and adopting mobile clinical trial models. These approaches aim to overcome geographical barriers and build trust within the community.
The authors also highlight the importance of considering disease prevalence within racial categories when designing clinical trials, particularly given the higher risk of diseases like type 2 diabetes and cancer, as well as higher rates of cancer deaths, COVID-19 morbidity, and asthmatic episodes within the Native Hawaiian and Pacific Islander population. For example, Native Hawaiians and Pacific Islanders experience worse survival rates in advanced melanoma cancer, a disease directly addressed in two of the included drug trials.
Study Limitations
The study's limitations include its focus on only ten drug trials and the FDA's first approvals. Future research could explore a broader range of trials and investigate disease prevalence by racial categories to further inform strategies for improving minority representation in clinical research.
