American Indian, Native Hawaiian data ‘effectively nonexistent’ in cancer trials
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Key takeaways:
- American Indian/Alaska Native and Native Hawaiian data often not in published phase 2/phase 3 cancer trials.
- Information on Black or African American and Hispanic individuals lacking too.
Most phase 2/phase 3 oncology clinical trials do not report American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander racial categories in their studies, according to findings published in JAMA Health Forum.
Additionally, information on Black or African American as well as Hispanic patients continues to lag.
“We anticipated low representation numbers for indigenous populations; however, the representation quotient — the ratio of published individuals in clinical trials relative to the number of individuals with cancer by race — was not just low, but zero for both American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander populations,” Kekoa Taparra, MD, PhD, MPH, resident in radiation oncology/radiation therapy at Stanford Medicine, told Healio. “This indicates that these groups are not just underrepresented, they are effectively nonexistent in the published data. This level of exclusion is alarming and highlights a critical area where immediate improvements are necessary.”
Background and methodology
The Affordable Care Act mandated the U.S. Department of Health and Human Services establish standards for collection and reporting of race and ethnicity data in 2010 based on five definitions established in 1997 — American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and white, with Hispanic ethnicity, according to background data researchers provided.
Historically, cancer clinical trials have not had patient populations reflective of the country’s diversity, leading to an information gap that can increase disparities among different racial and ethnic groups.
“It is well understood that indigenous populations in the United States face stark cancer and overall health disparities,” Taparra said. “These disparities are exacerbated by the phenomenon of indigenous erasure through data aggregation and omission, which keeps critical data hidden from those in power who could address our community's struggles.”
Researchers used PubMed/Embase to review phase 2/ phase 3 trials published in JAMA, Journal of Clinical Oncology (JCO), The Lancet, and New England Journal of Medicine (NEJM) between 2012-2022. They included studies of the most common noncutaneous solid tumors in the U.S.
Exclusions included trials with international lead authors, those investigating multiple cancers or not assessing treatment.
The cohort consisted of 364 publications (241 in JCO; 88 in NEJM; 19 in The Lancet; 16 in JAMA; 95% multicenter; 79% randomized; 60% phase 3), which included 268,209 patients (64% women) and had a median of 356 per study.
Researchers evaluated reporting rates of race and ethnicity as the study’s primary endpoint.
A representation quotient less than one indicated underrepresentation.
Results and next steps
Of the 364 publications reviewed, 71% included race and ethnicity data.
In all, 70% of studies included information on white patients, 59% on Black, 54% on Asian, 45% on other, 14% on American Indian or Alaska Native, and 8% on Native Hawaiian or Other Pacific Islander.
Both American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander populations had representation quotients (RQs) of zero.
“American Indian/Alaska Native and Native Hawaiian/Other Pacific Islander populations are often excluded due to several factors,” Taparra said. “Historically, there has been a lack of infrastructure for cancer clinical trials in remote Pacific regions and Indian reservations, coupled with limited resources to support academic medicine in these areas. Additionally, there is a lack of understanding and awareness of these populations on the continental U.S., along with structurally racist data practices that aggregate or omit our data.”
Conversely, Asian had a representation quotient of 1.04 (interquartile range, 0.09-4.77), followed by non-Hispanic individuals (RQ = 1.04; 1.01-1.06) and white (RQ = 0.98; 0.86-1.06).
Hispanic (RQ = 0.6; 0.37-0.82) and Black or African American (RQ = 0.42; 0.12-0.75) populations also had underreported data.
“Many clinical scholars argue that historically marginalized communities should actually have representation quotients greater than 1 to ensure adequate inclusion in trials and sample sizes sufficient for statistical analysis,” Taparra said. “Importantly, this often does not come at the expense of the majority populations because it is proportional. While low numbers of representation are better than zero representation, they still indicate significant disparities that need to be addressed. The fact that Black and Hispanic patients are underrepresented, though better than zero, is still inadequate and calls for improved efforts to ensure these populations are properly included in clinical trials.”
RQs significantly varied based on cancer site (P < .001) except for endometrial cancer.
Taparra noted the need for research into why indigenous populations are excluded from trials and how to bring more studies to those groups.
“I want to stress the importance of a culturally competent and diverse physician-scientist workforce that can integrate into these communities to earn their trust,” Taparra said. “This will help indigenous populations understand both the safety and impact that participating in clinical trials can have on their community's health. There must be larger financial investments not only in funding these locations but also in training personnel who can educate the next generation of clinical trialists and clinical research staff. This will ensure the sustainability of these programs moving forward. Building a robust, diverse and culturally aware health care workforce is essential to addressing these disparities and improving health outcomes for marginalized communities.”
For more information:
Kekoa Taparra, MD, PhD, MPH, can be reached at ktaparra@stanford.edu.
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