Racial and Ethnic Inequities in US Oncology Clinical Trial Participation From 2017 to 2022

Abstract

ImportanceThere is increasing recognition from regulatory agencies that racial and ethnic representation in clinical trials is inadequate and linked to health inequities. The extent of racial inequities in clinical trial participation is unclear because prior studies have synthesized enrollment data from published trials, which often do not report participant race and ethnicity.ObjectiveTo evaluate racial and ethnic inequities in oncology clinical trial participation in a contemporary cohort of patients with cancer before and during the COVID-19 pandemic.Design, Setting, and ParticipantsThis cohort study used a nationwide electronic health record–derived deidentified database, which includes data for approximately 280 US cancer clinics (approximately 800 sites of care). The study included Latinx, non-Latinx Black (hereinafter, Black), and non-Latinx White (reference; hereinafter, White) patients aged 18 years or older who had been diagnosed with advanced non–small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, multiple myeloma, or metastatic pancreatic cancer between January 1, 2017, and June 30, 2022 (follow-up through December 31, 2022). Data analysis was performed between August 1, 2022, and February 7, 2023.ExposuresElectronic health record–documented race and ethnicity.Main Outcomes and MeasuresThe main outcome was oncology trial participation (ie, receipt of a clinical study drug). Stratified cause-specific hazard models were used to estimate adjusted hazard ratios (HRs) and 95% CIs for likelihood of participation. Participation was assessed overall, by cancer type, and by period of diagnosis (2017-2019 vs 2020-2022).ResultsOf the 50 411 patients in this study, 28 878 (57.3%) were women and 21 533 (42.7%) were men. Black and Latinx patients were younger than White patients, with a median age of 65 (IQR, 57-72), 64 (IQR, 54-73), and 68 (IQR, 60-76) years, respectively. Oncology trial participation was lower among Black patients (307 of 6912 [4.4%]) and Latinx patients (166 of 3973 [4.2%]) relative to White patients (2858 of 39 526 [7.2%]) over the entire study period. Inequities in participation were observed across the 5 cancer types studied, with notably large inequities observed among Black patients (HR, 0.54 [95% CI, 0.36-0.81]) and Latinx patients (HR, 0.46 [95% CI, 0.27-0.77]) with metastatic pancreatic cancer. Moreover, inequities between Black and White patients in terms of participation widened among those diagnosed in the COVID-19 era (2020-2022: HR, 0.49 [95% CI, 0.40-0.60] vs 1.00 [95% CI, 0.93-1.09]) relative to those diagnosed before the pandemic (2017-2019: HR, 0.61 [95% CI, 0.53-0.70] vs 1 [reference]).Conclusions and RelevanceThe findings of this cohort study suggest that oncology trial participation was lower among Black and Latinx patients relative to White patients across all 5 cancer types examined. These findings, including potentially widening inequities in the COVID-19 era, support the need for regulatory guidance to improve enrollment of participants from historically excluded racial and ethnic populations in clinical trials.

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“…Almost 32% of our study participants were from underserved populations, which far exceeds the rates of enrollments into oncology studies in the US. Recently published data from 2017 to 2022 demonstrate that only 4.4% and 4.2% of the Black and Latino patients participated in oncology trials, respectively [ 22 ]. Finally, the design of our real-world study also allowed for sufficient follow-up data that were critical for assessing survival outcomes.…”

Multi-cancer early detection (MCED) tests: prioritizing equity from bench to bedside

“…Unfortunately, this problem is not unique to MCED-related trials. 18 Clinical trials with homogenous, predominantly White participants will likely decrease patient trust and acceptance of the novel technologies being tested, particularly if patients’ demographic backgrounds are not represented in the trials. In fact, leading governmental and funding agencies deem diversification of clinical trial representation a high priority to achieve care equity.…”

Incorporating Real-World Clinico-Genomic Insights to Inform Diversity Enrollment Targets in Oncology Trials

“…1 Recent assessments have shown notably lower participation rates among Black and Hispanic/Latino patients compared to their White counterparts, across multiple cancer types. 2 This discrepancy is compounded by the frequent absence of disaggregated race and ethnicity (R/E) data in clinical trial reports 3 obscuring the ability to monitor and address these disparities effectively. This lack of diversity not only challenges the generalizability of trial outcomes but also perpetuates existing health inequities by limiting the ability to deliver treatments that benefit diverse patient populations.…”