Major age, race, and ethnicity representation disparities exist within patients who participated in advanced renal cell carcinoma (aRCC) research, according to an abstract published in the Journal of Clinical Oncology after presentation at the 2023 American Society of Clinical Oncology annual meeting.1

To determine these representation disparities, the researchers examined the age, race, and ethnicity of patients with aRCC in real-world evidence (RWE), corresponding randomized controlled trials (RCTs), and Surveillance, Epidemiology, and End Results (SEER) data during overlapping periods between 2017 and 2022. The researchers analyzed the age, race, and ethnicity of 4821 patients with aRCC (RWE study: n = 635 [13.2%]; RCTs: Checkmate 214, n = 1096, and Keynote 426, n = 861 [40.6% across both RCTs]; SEER: n = 2229 [46.2%]).

In terms of age, the researchers found that RCT participants were younger at metastatic diagnosis (60.9 vs 65.1 years) and at first-line therapy initiation (60.9 vs 65.7 years) compared with patients in RWE and SEER, respectively (both P < .0001).

As for race and ethnicity, Black patients accounted for 17.2% in RWE, 1.6% in RCT, and 4.8% in SEER data. Asian patients accounted for 6.3%, 11.8%, and 6.0%, respectively, and Hispanic patients accounted for 15.0%, 3.4%, and 19.7%. From these results, researchers discovered that Hispanic patients were better represented within RWE studies than RCT studies (15.0% vs 3.4%; P < .001). White patients were the best-represented group as they accounted for 71.7% in RWE, 84.5% in RCT, and 67.5% in SEER data.

Based on this data, the researchers identified major disparities in the representation of patients of varying ages, races, and ethnicities within aRCC research. Overall, RCTs had a lower representation of older, Black, and Hispanic patients with aRCC compared with SEER and RWE studies.

“Despite limitations including sparse data available among Hispanics in RCTs, RWE studies can provide greater visibility to traditionally medically underrepresented patients with aRCC,” the authors wrote.

Dangers of a Lack of Representation

Lack of representation is not specific to aRCC research, instead affecting a variety of clinical studies, according to a consensus study report published last year by the National Academies of Sciences, Engineering, and Medicine, Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups.2

The authors noted that the overarching goal of the US investment in biomedical research is to improve the health and well-being of the entire US population, and the lack of representation within clinical research poses many threats to this.

One threat lack of representation poses is compromising the generalizability of clinical research findings. The authors cited research showing that RCTs exclude or underrepresent many groups that have distinct disease presentations or health circumstances, ultimately affecting their responses to an investigational drug or therapy. Because of this, RCTs cannot be considered generalizable.

Lack of representation may also lead to a lack of access to effective medical interventions for underrepresented groups. Because the approval and indications for new therapeutics are often restricted to the demographics of the populations studied, the groups excluded can be denied access to the respective therapeutic agents.

Lastly, lack of representation in clinical studies worsens health disparities within underrepresented populations and prevents the achievement of health equity. The CDC notes that health equity requires valuing everyone equally and addressing “avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities.”3

The National Academies report claimed that having diverse representation of patients within clinical research can help to make strides toward health equity.

“While achieving health equity and reducing health disparities requires far more than just equitable representation in clinical research, failure to achieve equity on this dimension leaves health disparities unaddressed and reinforces inequities,” the authors wrote.3

References

1. Garretson M, Gentile D, Brown B, et al. Representation of age, race and ethnicity in real-world evidence (RWE), randomized clinical trial (RCT), and Surveillance, Epidemiology, and End Results (SEER) cancer patient registry data in advanced renal cell carcinoma (aRCC). J Clin Oncol. 2023;41(suppl 16):e18672. doi:10.1200/JCO.2023.41.16_suppl.e18672

2. National Academies of Sciences, Engineering, and Medicine. Why diverse representation in clinical research matters and the current state of representation within the clinical research ecosystem. In: Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. The National Academies Press; 2022.

3. What is health equity? CDC. December 16, 2022. Accessed June 23, 2023. https://www.cdc.gov/nchhstp/healthequity/index.html