Quantifying the Silence in Oncology Trials

We examined the current clinical landscape to diagnose the systemic failure to count, name, and treat our Pacific Island communities.

The pharmaceutical industry suffers from a peculiar form of selective blindness. It has the optical acuity to identify a molecule that binds to a specific protein on a cancer cell yet loses all high-definition capability when asked to identify the human beings swallowing the resulting pill. A review of the ten drug products with the highest worldwide sales forecasts exposed a level of incuriosity that borders on malpractice. In a cross-sectional study of some 139k individuals involved in these marquee trials, the FDA approval applications for 60% of the products failed to document the number of Native Hawaiian and Pacific Islander (NHPI) participants entirely. The data simply does not exist.

We are not discussing obscure remedies for forgotten ailments. These are the titans of the pharmacopeia: Pembrolizumab for melanoma, Semaglutide for type 2 diabetes, and the BNT162b2 COVID-19 vaccine. The machinery of modern medicine grinds forward with tremendous momentum and generates billions in revenue, yet it operates on a dataset that has effectively excised the Pacific from its geography. When the trials did bother to count, the numbers were anemic. All trials reporting NHOPI (Native Hawaiian and Other Pacific Islander) participation showed enrollment levels below the population's proportional representation in the United States.

One must appreciate the absurdity of the specific figures to understand the scale of the insult. For Risankizumab-rzaa, a treatment for plaque psoriasis, the total number of NHOPI participants was 8. For the HIV regimen Bictegravir/emtricitabine/tenofovir alafenamide, the number was 7. It is statistically hallucinations to suggest that safety and efficacy profiles can be extrapolated to a diverse population based on a sample size that would not fill a large dinner table.

In fact, the laziness of the nomenclature drives this erasure. Since 1997, the US Office of Management and Budget has mandated the separation of Asian and Native Hawaiian or Pacific Islander into distinct racial categories. The federal bureaucracy moves with the speed of a tectonic plate, yet nearly three decades should have been sufficient to update a dropdown menu. It was not. Clinical researchers continue to rely on the Asian aggregate or the nebulous Other category. This failure to disaggregate is pernicious because it inflates the perceived diversity of the Asian cohort while simultaneously rendering the NHPI experience invisible. It conflates the physiology and medical history of a Japanese national with that of a CHamorro individual from Guam, assuming a biological and cultural interchangeability that exists nowhere outside the minds of Western statisticians.

This statistical invisibility has somatic consequences as the body keeps the score even if the FDA does not. NHPI individuals face a 75% increased likelihood of dying from liver cancer compared to caucasian populations. They endure a two-to-three-fold higher risk of mortality from cervical, stomach, and endometrial cancers. The disparity is a measurement of necrosis within the healthcare system. The population with the highest risk for type 2 diabetes and specific carcinomas is the very population most frequently excluded from the trials designed to treat those afflictions.

Also, we observe a friction in the mechanism of recruitment. The pharmaceutical sponsors argue that these populations are geographically diffuse or difficult to engage. They claim the logistics prevent adequate enrollment. This is pure deflection since the largest NHPI populations reside in Hawaiʻi and California, regions that are hardly inaccessible to modern commerce, so the barrier is not geography but actually trust and language.

For, mistrust in the US healthcare system remains a primary pathogen inhibiting recruitment. This skepticism is a rational response to historical trauma and colonization. When a researcher approaches a community with a clipboard and a consent form written in impenetrable Legalese, the interaction is doomed to failure before it begins. Language barriers and cultural dissonance are like a membrane that repels participation. So, the industry attempts to bypass this by recruiting globally, forcing the biological data of international patients to serve as a proxy for US populations. This improves the speed of recruitment but degrades the applicability of the results to the patients in the American healthcare system.

Now, there is a shift on the horizon, though one should view it with a healthy dose of skepticism until the ink dries. The Food and Drug Omnibus Reform Act (FDORA) now requires diversity action plans for Phase 3 trials. Sponsors must justify their enrollment targets and explain how they intend to reach underrepresented groups. This mandate creates a compliance necessity where moral obligation previously failed. The companies will need to find these patients, and they will need to speak to them.

This is where the linguistic strategy in the trial becomes the primary variable for success. It is impossible to generate enrollment momentum if the invitation is unintelligible. For, the translation of clinical protocols is a structural intervention. Healthcare providers cannot just wing it through a GPT model to pass from English to Samoan or Tongan. We have to dismantle the friction that exists between the standardized requirements of the protocol and the lived reality of the patient. The documentation must be precise enough to satisfy the regulator and sound enough to satisfy the grandmother in Honolulu who remembers a history of medical neglect.

Our agency operates in this fissure. We understand that the failure to recruit is often a failure to translate. The generic Other category is a linguistic surrender because it admits that the system cannot be bothered to name the person standing in front of it. By insisting on precise, culturally calibrated communication, we force the system to acknowledge the distinct existence of these communities.

Therefore, the medical establishment must move beyond the inertia of the Asian bucket. It must establish recruitment sites where the people actually live, rather than expecting the people to migrate to the convenience of the researcher. Postmarket studies are necessary to compensate for the failures of the premarket trials, but they are a palliative measure.

The 60% non-reporting rate for NHPI participation is an indictment of the current standard of care. It suggests that for the majority of top-selling drugs, the industry is content to operate in the dark regarding Pacific Islander physiology. Well, we reject this entropy because the data is available and the patients are waiting. The only thing missing is the will to speak their language and the decency to write down their names.

So, no, the path forward does not require us to invent new science. but actually requires us to apply the rigors of the scientific method to the process of inclusion itself. Until the n-number for a Pacific Islander cohort rises above single digits, the claim that a drug is "safe and effective for all" remains a marketing slogan. We will continue to sharpen the syntax of these trials until the data reflects the human reality it claims to measure.