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      Is Open Access

      Why location matters: associations between county-level characteristics and availability of National Cancer Oncology Research Program and National Cancer Institute sites

      research-article
      , PhD, MPH , , DrPH, , ScD, , PhD, , PhD, MBA, , PhD, MPH, , MD, MSPH
      JNCI Cancer Spectrum
      Oxford University Press

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          Abstract

          Background

          The majority of patients with cancer seek care at community oncology sites; however, most clinical trials are available at National Cancer Institute (NCI)–designated sites. Although the NCI National Cancer Oncology Research Program (NCORP) was designed to address this problem, little is known about the county-level characteristics of NCORP site locations.

          Methods

          This cross-sectional analysis determined the association between availability of NCORP or NCI sites and county-level characteristic theme percentile scores from the Center for Disease Control and Prevention’s Social Vulnerability Index themes. Health Resources and Services Administration’s Area Health Resource Files were used to determine contiguous counties. We estimated risk ratios and 95% confidence intervals (CIs) using modified Poisson regression models to evaluate the association between county-level characteristics and site availability within singular and singular and contiguous counties.

          Results

          Of 3141 included counties, 14% had an NCORP, 2% had an NCI, and 1% had both sites. Among singular counties, for a standard deviation increase in the racial and ethnic theme score, there was a 22% higher likelihood of NCORP site availability (95% CI = 1.10 to 1.36); for a standard deviation increase in the socioeconomic status theme score, there was a 24% lower likelihood of NCORP site availability (95% CI = 0.67 to 0.87). Associations were of smaller magnitude when including contiguous counties. NCI sites were located in more vulnerable counties.

          Conclusions

          NCORP sites were more often in racially diverse counties and less often in socioeconomically vulnerable counties. Research is needed to understand how clinical trial representation will increase if NCORP sites strategically increase their locations in more vulnerable counties.

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          Most cited references42

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          How Structural Racism Works — Racist Policies as a Root Cause of U.S. Racial Health Inequities

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            More than Tuskegee: understanding mistrust about research participation.

            This paper describes results of a qualitative study that explored barriers to research participation among African American adults. A purposive sampling strategy was used to identify African American adults with and without previous research experience. A total of 11 focus groups were conducted. Groups ranged in size from 4-10 participants (N=70). Mistrust of the health care system emerged as a primary barrier to participation in medical research among participants in our study. Mistrust stems from historical events including the Tuskegee syphilis study and is reinforced by health system issues and discriminatory events that continue to this day. Mistrust was an important barrier expressed across all groups regardless of prior research participation or socioeconomic status. This study illustrates the multifaceted nature of mistrust, and suggests that mistrust remains an important barrier to research participation. Researchers should incorporate strategies to reduce mistrust and thereby increase participation among African Americans.
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              Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

              What is the status of reporting and representation of racial/ethnic groups in landmark trials leading to US Food and Drug Administration (FDA) approval of oncology drugs? In 230 trials leading to FDA oncology drug approvals over the past decade, race was reported in only 145 (63%) trials. Compared with whites (98% of expected proportion), blacks (22% of expected proportion) and Hispanics (44% of expected proportion) were underrepresented in these trials relative to their proportion among the US cancer population. Suboptimal race reporting and representation (especially in blacks and Hispanics) occurs regularly in landmark oncology trials and increased efforts are needed to enhance minority representation and eliminate these disparities. This database study assesses the frequency of race reporting and proportional race representation in trials that support FDA oncology drug approvals. Representative racial/ethnic participation in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in health care. To evaluate the frequency of race reporting and proportional race representation in trials supporting US Food and Drug Administration (FDA) oncology drug approvals. Database study of all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. Primary reports of trials were obtained from PubMed and ClinicalTrials.gov. Food and Drug Administration approvals were identified using the FDA archives. The US population-based cancer estimates by race were calculated using National Cancer Institute–Surveillance, Epidemiology, and End Results and US Census databases. Primary outcomes were the proportion of trials reporting race and the proportion of patients by race participating in trials. Secondary outcomes included race subgroup analyses reporting and gaps between race proportion in trials and the US population. Descriptive statistics, Fisher exact, and χ 2 tests were used to analyze the data. Proportions and odds ratios (OR) with 95% CIs were reported. Among 230 trials with a total of 112 293 participants, 145 (63.0%) reported on at least 1 race, 18 (7.8%) documented the 4 major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively. Between July 2008 and June 2013 vs July 2013 and June 2018, the number of trials reporting race (45 [56.6%] vs 100 [67.1%]; OR, 1.63; 95% CI, 0.93-2.87; P  = .09) and race subgroup analysis (13 [16.1%] vs 45 [30.2%]; OR, 2.26, 95% CI, 1.16-4.67; P  = .03) changed minimally and varied across races. Whites, Asians, blacks, and Hispanics represented 76.3%, 18.3%, 3.1% and 6.1% of trial participants, respectively, and the proportion for each race enrolled over time changed nominally (blacks, 3.6% vs 2.9% and Hispanics, 5.3% vs 6.7%) from July 2008 to June 2013 vs July 2013 to June 2018. Compared with their proportion of US cancer incidence, blacks (22% of expected) and Hispanics (44% of expected) were underrepresented compared with whites (98% of expected) and Asians (438% of expected). Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Role: ConceptualizationRole: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Role: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Role: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Role: ConceptualizationRole: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Role: ConceptualizationRole: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Role: ConceptualizationRole: Formal analysisRole: Writing - original draftRole: Writing - review & editing
                Journal
                JNCI Cancer Spectr
                JNCI Cancer Spectr
                jncics
                JNCI Cancer Spectrum
                Oxford University Press
                2515-5091
                June 2024
                14 May 2024
                14 May 2024
                : 8
                : 3
                : pkae038
                Affiliations
                Division of Hematology and Oncology, Department of Medicine, University of Alabama at Birmingham (UAB) , Birmingham, AL, USA
                Division of Preventive Medicine, University of Alabama at Birmingham Department of Medicine , Birmingham, AL, USA
                O’Neal Comprehensive Cancer Center, University of Alabama at Birmingham , Birmingham, AL, USA
                Department of Epidemiology, University of Alabama at Birmingham School of Public Health , Birmingham, AL, USA
                Department of Epidemiology, University of Alabama at Birmingham School of Public Health , Birmingham, AL, USA
                University of Alabama at Birmingham School of Nursing , Birmingham, AL, USA
                Department of Health Policy and Management, Gillings School of Public Health, University of North Carolina (UNC) , Chapel Hill, NC, USA
                University of North Carolina Lineberger Comprehensive Cancer Center , Chapel Hill, NC, USA
                Division of Hematology and Oncology, Department of Medicine, University of Alabama at Birmingham (UAB) , Birmingham, AL, USA
                O’Neal Comprehensive Cancer Center, University of Alabama at Birmingham , Birmingham, AL, USA
                Author notes
                Correspondence to: Nicole E. Caston, PhD, MPH, Division of Hematology and Oncology, Department of Medicine, University of Alabama at Birmingham, BDB Suite 850A, Birmingham, AL 35294, USA (e-mail: ncaston@ 123456uab.edu ).
                Author information
                https://orcid.org/0000-0001-7474-6110
                https://orcid.org/0000-0001-8294-3851
                Article
                pkae038
                10.1093/jncics/pkae038
                11163183
                38745369
                83baa36a-a7d1-4e85-aa1a-457add8e3f5e
                © The Author(s) 2024. Published by Oxford University Press.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 November 2023
                : 30 January 2024
                : 3 May 2024
                : 10 June 2024
                Page count
                Pages: 10
                Funding
                Funded by: O’Neal NextGen Predoctoral Scholar;
                Funded by: Breast Cancer Research Foundation of Alabama, DOI 10.13039/100016419;
                Categories
                Article
                AcademicSubjects/MED00010

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