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. 2021 Nov 1;4(11):e2133205.
doi: 10.1001/jamanetworkopen.2021.33205.

Racial and Ethnic Disparities Among Participants in Precision Oncology Clinical Studies

Christopher M Aldrighetti  1 , Andrzej Niemierko  1 , Eliezer Van Allen  2   3   4 , Henning Willers  1 , Sophia C Kamran  1   3
Affiliations

Racial and Ethnic Disparities Among Participants in Precision Oncology Clinical Studies

Christopher M Aldrighetti et al. JAMA Netw Open. .

Abstract

Importance: Precision oncology is revolutionizing cancer care, allowing for personalized treatments to improve outcomes. Cancer research has benefitted from well-designed studies incorporating precision medicine objectives, but it is unclear if these studies are representative of the diverse cancer population.

Objective: To evaluate racial and ethnic representation in breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives in the Clinicaltrials.gov registry and compare with the incidence of these cancer types in racial and ethnic minority groups in the US population.

Design, setting, and participants: This cross-sectional study identified US-based breast, prostate, lung, and colorectal cancer studies incorporating precision oncology objectives for reporting of race and ethnicity. The Surveillance, Epidemiology, and End Results and US Census databases were used to determine cancer incidence by race and ethnicity, linked with cancer type and median year of enrollment for each trial. Data were collected and analyzed between December 2020 and April 2021.

Main outcomes and measures: The expected number of participants per study by each racial and ethnic group was calculated based on the corresponding US-based proportion. Under- and overrepresentation was defined as the ratio of the actual number of enrolled cases to the expected number of cases for each trial by cancer type. Ratios above 1 indicated overrepresentation while a ratio below 1 indicated underrepresentation. Random-effects meta-analysis of representation ratios of individual trials was performed to weigh each individual study.

Results: Of 93 studies encompassing 5867 enrollees with race and ethnicity data; 4826 participants (82.3%) were non-Hispanic White, 587 (10.0%) were Black, and 238 (4.1%) were Asian. Per observed-to-expected ratios, White participants were overrepresented in all studies, with a ratio of 1.35 (95% CI, 1.30-1.37), as well as Asian participants, with a ratio of 1.46 (95% CI, 1.28-1.66), while Black participants (ratio, 0.49; 95% CI, 0.45-0.54), Hispanic participants (ratio, 0.24; 95% CI, 0.20-0.28), and American Indian and Alaskan Native participants (ratio, 0.43; 95% CI, 0.24-0.78) were underrepresented. By individual cancer site, White participants were consistently overrepresented in all studies, while Black and Hispanic participants were underrepresented.

Conclusions and relevance: This analysis found that precision oncology studies for breast, lung, prostate, and colorectal cancers vastly underrepresent racial and ethnic minority populations relative to their cancer incidence in the US population. It is imperative to increase diversity among enrollees so that all individuals may benefit from cancer research breakthroughs and personalized treatments.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kamran reported having a spouse who is employed by Sanofi Genzyme. Dr Van Allen reported advisory and consulting work for Tango Therapeutics, Genome Medical, Invitae, Enara Bio, Janssen, Manifold Bio, and Monte Rosa; he reported research support from Novartis, BMS; he reported equity in Tango Therapeutics, Genome Medical, Syapse, Enara Bio, Manifold Bio, Microsoft, and Monte Rosa; he received travel reimbursement from Roche/Genentech; and he filed institutional patents on chromatin mutations and immunotherapy response and methods for clinical interpretation outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Schema and Race and Ethnicity Reporting in Precision Oncology Clinical Studies
Figure 2.
Figure 2.. Racial and Ethnic Disparities in Precision Oncology Trials Compared to US Cancer Population
Dots represent ratio; whiskers, 95% CI. Ratios below the dotted line indicate underrepresentation in oncology study enrollment.
See this image and copyright information in PMC

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