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Underrepresentation of Racial and Ethnic Minorities in Metastatic Colorectal Carcinoma Clinical Trials Within the
Tracey Pu1, Alexandra Gustafson1, Kenneth Luberice1
1Surgical Oncology Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Objective:
To investigate whether underrepresentation of racial and ethnic minorities exists in metastatic colorectal carcinoma (CRC) clinical trials.
Background:
Representation of vulnerable subpopulations is essential for the generalizability of clinical trials. Limited studies to date have investigated the racial and ethnic representation of patients enrolled in clinical trials for metastatic CRC.
Methods:
ClinicalTrials.gov was queried for metastatic CRC clinical trials in the United States from 2000 to 2020. Incidence data were extracted from the SEER Database. Enrollment fraction was defined as the number of trial participants divided by U.S. incidence of metastatic CRC in each race, ethnicity, and sex. Representation quotient (RQ) was defined as the proportion of trial participants divided by the proportion of U.S. metastatic CRC incidence for each subgroup.
Results:
A total of 8084 patients from 135 clinical trials were analyzed. Of clinical trials, 49.6% reported race data and 34.8% reported ethnicity data. Compared with 2000 to 2009, 2010 to 2019 had increased representation data reporting for race (61.2% vs 38.8%) and ethnicity (64.6% vs 35.4%). Of trials with race data, White patients represented 77.0%, Black patients 6.6%, Asian/Pacific Islander patients 16.1%, American Indian/Alaska Native patients 0.2%, and Hispanic patients 6.8%. Black patients (median RQ: 0.54), Asian/Pacific Islander patients (median RQ: 0.19), American Indian/Alaska Native patients (median RQ: 0.00), and Hispanic patients (median RQ: 0.26) were underrepresented. Black patients had a higher degree of underrepresentation in clinical trials with serum creatinine inclusion criteria (RQ: 0.40 vs 0.86, P = 0.034).
Conclusions:
Strategies are needed to increase minority enrollment in clinical trials for metastatic CRC. Identification of systemic barriers is integral in public policy advocacy to increase representation.
Insights
Racial and ethnic minorities are underrepresented in metastatic colorectal cancer (CRC) clinical trials, particularly Black, Asian/Pacific Islander, American Indian/Alaska Native, and Hispanic patients. Strategies are needed to improve minority enrollment in CRC trials.
Area of Science:
- Oncology
- Clinical Trials
- Health Equity
Background:
- Generalizability of clinical trial findings relies on diverse participant representation.
- Limited research has examined racial and ethnic diversity in metastatic colorectal cancer (CRC) clinical trials.
Purpose of the Study:
- To investigate the underrepresentation of racial and ethnic minorities in U.S. clinical trials for metastatic colorectal carcinoma (CRC).
Main Methods:
- Analysis of metastatic CRC clinical trials registered on ClinicalTrials.gov (2000-2020) and incidence data from the SEER Database.
- Calculation of Enrollment Fraction (EF) and Representation Quotient (RQ) to assess subgroup participation relative to incidence.
- Evaluation of race and ethnicity data reporting trends over two decades.
Main Results:
- Across 135 trials and 8084 patients, reporting of race and ethnicity data improved from 2000-2009 to 2010-2019.
- White patients were overrepresented (77.0%), while Black (6.6%), Asian/Pacific Islander (16.1%), and Hispanic (6.8%) patients were underrepresented based on RQ.
- Significant underrepresentation was observed for Black, Asian/Pacific Islander, American Indian/Alaska Native, and Hispanic patients, with Black patients showing greater underrepresentation in trials with specific inclusion criteria.
Conclusions:
- Minority groups, including Black, Asian/Pacific Islander, American Indian/Alaska Native, and Hispanic populations, are underrepresented in metastatic CRC clinical trials.
- Targeted strategies are essential to enhance minority enrollment in these trials.
- Identifying and addressing systemic barriers is crucial for public policy and advocacy to improve representation.
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