Native Hawaiians/Pacific Islanders Found to be Underrepresented in Clinical Trials

Major clinical trials lack documentation and participation data on Native Hawaiians and Pacific Islanders, a recent study finds.

Native Hawaiian and Pacific Islanders had limited, if any, recorded documentation of their participation in clinical trials for 10 drugs with top sales forecasts, according to a recent study published in JAMA Oncology.

The study examined 139,062 patients participating in clinical trials involving 10 drugs with top sales forecasts and surveyed them for Native Hawaiians and Pacific Islanders. The population of Native Hawaiians and Pacific Islanders was counted as people with origins in Hawaii, Guam, American Samoa, the Republic of the Marshal Islands, and the Commonwealth of the Northern Mariana Islands, amongst many others.

The top 10 drugs surveyed included 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).

There are 1.7 million Native Hawaiian and Pacific Islanders living in the US, approximately 0.5% of the US population, according to 2021 US Census Data. From 2020 to 2021, their population grew by 1.5%, the largest amount of any racial group in the US.

Across all 10 drug products examined, 6 (60%) did not document the participation of any Native Hawaiians and Pacific Islanders, of which these trials were the basis of submission for FDA approval. The remaining 4 (40%) were assessed to have fewer participants in the study population than representative of their US population proportion.

“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 authors of the study said.

Researchers note the importance of this, particularly because Native Hawaiians and Pacific Islanders are at a greater risk of diseases like type 2 diabetes and cancer. Beyond this, the patient population also has higher rates of cancer deaths, COVID-19 morbidity, and asthmatic episodes.

Of the 10 clinical drug trials included in this study, 2 pertain directly to advanced melanoma cancer, a disease in which Native Hawaiians and Pacific Islanders have worse survival than non-Hispanic White patients.

Of the 4 trials that documentation was found, 2 were statistically significant and reached the .05 level. The first being 4vHPV/9vHPV, of which 27 patients were Native Hawaiian and Pacific Islander (0.15% of patients vs 0.46% of the population; percentage point difference, −0.31%; 95% CI, −0.37% to −0.26%) and the second being the BNT162B2 COVID-19 vaccine, of which 90 participants were in the patient population (0.20% vs 0.52%; −0.32; 95% CI, −0.36% to −0.27%).

The remaining 2 trials were for risankizumab-rzaa, which had 8 patients in the study population (0.38% of participants vs 0.49% of the population; percentage point difference, −0.11%; 95% CI, −0.37% to −0.15%) and bictegravir/emtricitabine/tenofovir alafenamide, which had 7 patients in the study population (0.38% vs 0.49%; percentage point difference, −0.10%; 95% CI, −0.39% to 0.18%).

Another area of concern for the authors was the grouping of Native Hawaiians and Pacific Islanders into an “Asian” grouping, rather than one of their own. Not only does this render the patient population invisible, but it also greatly inflates the percentage of Asian participants counted in a trial.

As methods of outreach to boost the participation of the study population, the study authors suggest establishing recruitment sites in Hawaii, setting up a referral network to engage Native Hawaiian and Pacific Islander communities, and adopting mobile clinical trial models.

Limitations include the scope of the study only expanding to 10 drug trials and a focus on the FDA’s first approvals.

A final consideration and avenue for future studies is the exploration and integration of disease prevalence by racial categories into the testing of medical possibilities regarding underrepresented minorities.

Reference

Taira DA, Ranken MS, Seto BK, et al. Representation of Native Hawaiian and Pacific Islander individuals in clinical trials. JAMA Netw Open. 2024;7(10):e2442204. doi:10.1001/jamanetworkopen.2024.42204