Gender, Age, Racial and Ethnic Disparities in Clinical Trial Enrollment for Primary Liver Cancer.
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ABSTRACT:
SUBMITTER: Jan J
PROVIDER: S-EPMC9232956 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
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Gender, Age, Racial and Ethnic Disparities in Clinical Trial Enrollment for Primary Liver Cancer.
Jan Jenny J Osho Azeez A Murphy Caitlin C CC Mazure Carolyn M CM Singal Amit G AG Rich Nicole E NE
Gastroenterology 20220312 1
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Project description:ImportanceRacial and ethnic disparities in clinical trial enrollment are unjust and hinder development of new cancer treatments.ObjectiveTo examine the association of race and ethnicity with clinical trial enrollment among women with endometrial, ovarian, or cervical cancer.Design, setting, and participantsThis retrospective cohort study used data from the National Cancer Database, a hospital-based cancer registry, and the Surveillance, Epidemiology, and End Results Program (SEER), a population-based cancer registry. Population-based race and ethnicity-specific proportions for each cancer site were derived from SEER. Participants included women with an endometrial, ovarian, or cervical cancer diagnosed from 2004 to 2019. Analyses were performed from February 2 to June 14, 2023.ExposureRace and ethnicity were categorized as American Indian/Alaska Native, Asian, Black, Hispanic (any race), Native Hawaiian/Pacific Islander, White, and other (not defined in the National Cancer Database).Main outcomes and measuresThe primary outcomes were the odds of clinical trial enrollment and representation in clinical trials compared with the US population. Multivariable-adjusted logistic regression was used to estimate odds ratios (ORs) and 95% CIs for associations of race and ethnicity with clinical trial enrollment within the National Cancer Database sample. Participation-to-prevalence ratios (PPRs) according to diagnosis period (2004-2011 vs 2012-2019) were calculated by dividing the race and ethnicity-specific percentage of clinical trial participants in the study sample by the percentage of racial and ethnic groups in SEER.ResultsAmong 562 592 patients with gynecologic cancer (mean [SD] age at diagnosis, 62.9 [11.3] years), 1903 were American Indian/Alaska Native, 18 680 were Asian, 56 421 were Black, 38 145 were Hispanic, 1453 were Native Hawaiian/Pacific Islander, 442 869 were White, and 3121 were other race and ethnicity. Only 548 (<1%) were enrolled in clinical trials. Compared with White women, clinical trial enrollment was lower for Asian (OR, 0.44; 95% CI, 0.25-0.78), Black (OR, 0.70; 95% CI, 0.50-0.99), and Hispanic (OR, 0.53; 95% CI, 0.33-0.83) women. Compared with the US population, White women were adequately or overrepresented for all cancer types (PPRs ≥1.1), Black women were adequately or overrepresented for endometrial and cervical cancers (PPRs ≥1.1) but underrepresented for ovarian cancer (PPR ≤0.6), and Asian and Hispanic women were underrepresented among all 3 cancer types (PPRs ≤0.6).Conclusions and relevanceIn this cohort of patients with gynecologic cancer, clinical trial enrollment was lower among certain minoritized racial and ethnic groups. Continued efforts are needed to address disparate clinical trial enrollment among underrepresented groups.
| S-EPMC10704282 | biostudies-literature
Project description:Data regarding racial and ethnic enrollment diversity for acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) clinical trials in the United States are limited, and little is known about the effect of federal reporting requirements instituted in the late 2000s. We examined demographic data reporting and enrollment diversity for ALL and AML trials in the United States from 2002 to 2017, as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML trials and 97 ALL trials with results on ClinicalTrials.gov, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML, n = 6554; ALL, n = 4149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared with NH-White patients after adjusting for race-ethnic disease incidence (AML odds ratio, 0.68, 0.31, 0.75, and 0.83, respectively; ALL odds ratio, 0.74, 0.27, 0.67, and 0.64; all, P ≤ .01). The proportion of trials reporting race increased significantly after implementation of the reporting requirements (44.2% to 60.2%; P = .02), but race-ethnicity reporting did not (34.8% to 38.6%; P = .57). Reporting proportions according to number of patients enrolled increased significantly after the reporting requirements were instituted (race, 51.7% to 72.7%; race-ethnicity, 39.5% to 45.4%; both, P < .001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds ratio, 0.79 and 0.77; ALL odds ratio, 0.35 and 0.25; both P ≤ .01). These data suggest that demographic enrollment reporting for acute leukemia trials is suboptimal, changes in diversity after the reporting requirements may be due to additional enrollment disparities that were previously unreported, and enrollment diversification strategies specific to acute leukemia care delivery are needed.
| S-EPMC8579250 | biostudies-literature
Project description:BackgroundIn 2020, primary care practices adopted telemedicine as an alternative to in-person visits. Little is known about whether access to telemedicine was equitable, especially among older patients. Our objectives were to (1) examine older adults' use of telemedicine versus in-person primary care visits and (2) compare hospitalization for ambulatory care sensitive conditions (ACSCs) between the groups.MethodsIn this retrospective cross-sectional study of 17,103 patients aged ≥65 years seen at 32 clinics in the Mid-Atlantic, primary care patients were classified into two groups-telemedicine versus in person-based on the first visit between March and May 2020 and followed up for 14 days. Using multivariable logistic regression, we measured the odds of being seen via telemedicine versus in person as a function of patient demographics, comorbidities, and week of study period. We then measured the odds of ACSC hospitalization by visit modality.ResultsMean age was 75.1 years (SD, 7.5), 60.6% of patients were female, 64.6% white, 28.1% black, and 2.0% Hispanic. Overall, 60.3% of patients accessed primary care via telemedicine. Black (vs. white) patients had higher odds of using telemedicine (adjusted odds ratio [aOR], 1.30; 95% CI, 1.14-1.47) and Hispanic (vs. not Hispanic) patients had lower odds (aOR, 0.63; 95% CI, 0.42-0.92). Compared with the in-person group, patients in the telemedicine group had lower odds of ACSC hospitalization (aOR, 0.78; 95% CI, 0.61-1.00). Among patients who used telemedicine, black patients had 1.43 higher odds of ACSC hospitalization (95% CI, 1.02-2.01) compared with white patients. Patients aged 85 or older seen via telemedicine had higher odds of an ACSC hospitalization (aOR, 1.60; 95% CI, 1.03-2.47) compared with patients aged 65-74.ConclusionsThese findings support the use of telemedicine for primary care access for older adults. However, the observed disparities highlight the need to improve care quality and equity regardless of visit modality.
| S-EPMC8497419 | biostudies-literature
Project description:Multiple myeloma (MM) is a hematological malignancy that is consistently preceded by an asymptomatic condition, monoclonal gammopathy of undetermined significance (MGUS). Disparities by age, gender, and race/ethnicity in both MGUS and MM are well-established. However, it remains unclear whether these disparities can be explained by increased incidence of MGUS and/or accelerated progression from MGUS to MM. Here, we fit a mathematical model to nationally representative data from the United States and showed that the difference in MM incidence can be explained by an increased incidence of MGUS among male and non-Hispanic Black populations. We did not find evidence showing differences in the rate of progression from MGUS to MM by either gender or race/ethnicity. Our results suggest that screening for MGUS among high-risk groups (e.g., non-Hispanic Black men) may hold promise as a strategy to reduce the burden and MM health disparities.
| S-EPMC10511740 | biostudies-literature
Project description:BackgroundClinical trial participation at Comprehensive Cancer Centers (CCC) is inequitable for minoritized racial and ethnic groups with acute leukemia. CCCs care for a high proportion of adults with acute leukemia. It is unclear if participation inequities are due to CCC access, post-access enrollment, or both.MethodsWe conducted a retrospective cohort study of adults with acute leukemia (2010-2019) residing within Massachusetts, the designated catchment area of the Dana-Farber/Harvard Cancer Center (DF/HCC). Individuals were categorized as non-Hispanic Asian (NHA), Black (NHB), White (NHW), Hispanic White (HW), or Other. Decomposition analyses assessed covariate contributions to disparities in (1) access to DF/HCC care and (2) post-access enrollment.ResultsOf 3698 individuals with acute leukemia, 85.9% were NHW, 4.5% HW, 4.3% NHB, 3.7% NHA, and 1.3% Other. Access was lower for HW (age- and sex-adjusted OR = 0.64, 95% CI = 0.45 to 0.90) and reduced post-access enrollment for HW (aOR = 0.54, 95% CI =0.34 to 0.86) and NHB (aOR = 0.60, 95% CI = 0.39 to 0.92) compared to NHW. Payor and socioeconomic status (SES) accounted for 25.2% and 21.2% of the +1.1% absolute difference in HW access. Marital status and SES accounted for 8.0% and 7.0% of the -8.8% absolute disparity in HW enrollment; 76.4% of the disparity was unexplained. SES and marital status accounted for 8.2% and 7.1% of the -9.1% absolute disparity in NHB enrollment; 73.0% of the disparity was unexplained.ConclusionsA substantial proportion of racial and ethnic inequities in acute leukemia trial enrollment at CCCs are from post-access enrollment, the majority of which was not explained by sociodemographic factors.
| S-EPMC11223832 | biostudies-literature
Project description:ObjectiveRacial and ethnic minority enrollees in Medicare Advantage (MA) plans tend to be in lower-quality plans, measured by a 5-star quality rating system. We examine whether differential access to high-rated plans was associated with this differential enrollment in high-rated plans by race and ethnicity among MA enrollees.Data sourcesThe Medicare Master Beneficiary Summary File and MA Landscape File for 2016.Study designWe first examined county-level MA plan offerings by race and ethnicity. We then examined the association of racial and ethnic differences in enrollment by star rating by controlling for the following different sets of covariates: (1) individual-level characteristics only, and (2) individual-level characteristics and county-level MA plan offerings.Data collection/extraction methodsNot applicable PRINCIPAL FINDINGS: Racial and ethnic minority enrollees had, on average, more MA plans available in their counties of residence compared to White enrollees (16.1, 20.8, 20.2, vs. 15.1 for Black, Asian/Pacific Islander, Hispanic, and White enrollees), but had fewer number of high-rated plans (4-star plans or higher) and/or more number of low-rated plans (3.5-star plans or lower). While racial and ethnic minority enrollees had lower enrollment in 4-4.5 star plans than White enrollees, this difference substantially decreased after accounting for county-level MA plan offerings (-9.1 to -0.5 percentage points for Black enrollees, -15.9 to -5.0 percentage points for Asian/Pacific Islander enrollees, and -12.7 to 0.6 percentage points for Hispanic enrollees). Results for Black enrollees were notable as the racial difference reversed when we limited the analysis to those who live in counties that offer a 5-star plan. After accounting for county-level MA plan offerings, Black enrollees had 3.2 percentage points higher enrollment in 5-star plans than White enrollees.ConclusionsDifferences in enrollment in high-rated MA plans by race and ethnicity may be explained by limited access and not by individual characteristics or enrollment decisions.
| S-EPMC10012240 | biostudies-literature
Project description:BackgroundThe existing data on enrollment trends of historically underserved racial and ethnic children in clinical trials are limited.ObjectiveWe sought to evaluate documentation and representation of race and ethnicity in pediatric asthma clinical trials in the United States.MethodsThis is a cross-sectional study of United States-based interventional trials studying pediatric asthma that were completed between 2008 and 2022 and registered on ClinicalTrials.gov. Enrollment disparities were assessed by using the measure enrollment prevalence difference (EPD) (defined as the median difference between the proportion of participants enrolled and asthma prevalence in the US population by race and ethnicity).ResultsOf the 67 trials reviewed, 53 (79.2%) and 36 (53.7%) reported on race and ethnicity at ClinicalTrials.gov, respectively. Most participants were White (39.1%), Black (37.1%), or non-Hispanic (66.1%). Black, Hispanic, multiracial, and White children were enrolled in the expected proportions based on their contribution to asthma burden. However, American Indian or Alaska Native (AI/AN) (EPD = -1 [95% CI = -1 to -1]) and Asian children (EPD = -3 [95% CI = -3 to -3]) were underrepresented relative to disease burden in these respective groups. Fewer Black children were enrolled in drug or device trials (β = -0.80 [95% CI = -1.60 to -0.01]) than in other trials. Fewer Hispanic children were enrolled in early-phase than late-phase trials (β = -2.42 [95% CI = -3.66 to -1.19]).ConclusionsEnrollment in pediatric asthma trials conducted in the United States was commensurate with the demographics of children affected by asthma for most racial and ethnic groups, but American Indian or Alaska Native and Asian children were underrepresented. Concerted efforts are needed to promote inclusion of these underserved groups in future trials.
| S-EPMC11372584 | biostudies-literature
Project description:Background and objectivesTo examine racial/ethnic, nativity, and gender differences in the benefits of educational attainment on cognitive health life expectancies among older adults in the United States.Research design and methodsWe used data from the Health and Retirement Study (1998-2014) to estimate Sullivan-based life tables of cognitively healthy, cognitively impaired/no dementia, and dementia life expectancies by gender for older White, Black, U.S.-born Hispanic, and foreign-born Hispanic adults with less than high school, high school, and some college or more.ResultsWhite respondents lived a greater percentage of their remaining lives cognitively healthy than their minority Black or Hispanic counterparts, regardless of level of education. Among respondents with some college or more, versus less than high school, Black and U.S.-born Hispanic women exhibited the greatest increase (both 37 percentage points higher) in the proportion of total life expectancy spent cognitively healthy; whereas White women had the smallest increase (17 percentage points higher). For men, the difference between respondents with some college or more, versus less than high school, was greatest for Black men (35 percentage points higher) and was lowest for U.S.-born Hispanic men (21 percentage points higher).Discussion and implicationsOur results provide evidence that the benefits of education on cognitive health life expectancies are largest for Black men and women and U.S.-born Hispanic women. The combination of extended longevity and rising prevalence of Alzheimer's disease points to the need for understanding why certain individuals spend an extended period of their lives with poor cognitive health.
| S-EPMC8023372 | biostudies-literature
Project description:ObjectiveThe objective of this study was to examine the representation of historically marginalized racial and ethnic groups in pediatric obesity clinical trials.MethodsWe performed a cross-sectional analysis of clinical trials in pediatric obesity (participants aged ≤18 years) that were registered in ClinicalTrials.gov, were completed from January 2013 to August 2023, and were conducted in the United States. We quantified disparities in trial enrollment by calculating the enrollment-prevalence disparity (EPD) for each racial and ethnic group.ResultsA total of 260 trials met eligibility criteria, of which 128 trials (49.2%) reported race and/or ethnicity data. Enrollment of White, Hispanic, and Black children roughly reflects disease burden in these populations. However, relative to disease burden, Asian (EPD, -3.7%; IQR, -3.7% to 1.8%; p < 0.0001), American Indian and Alaska Native (EPD, -2.1%; IQR, -2.1% to -2.1%; p < 0.0001), and Native Hawaiian or other Pacific Islander (EPD, -0.6%; IQR, -0.6% to -0.6%; p < 0.0001) children were significantly underrepresented in these trials.ConclusionsWith the exception of Black and Hispanic children, historically marginalized racial groups were underrepresented in pediatric obesity trials, signifying a need to improve diversity of participants in these trials. Additionally, there are substantial gaps in the documentation of race and ethnicity information. Concerted efforts are needed to ensure adequate reporting of race and ethnicity information in clinical trials.
| S-EPMC11903186 | biostudies-literature
Project description:ImportanceThe disease burden for primary open-angle glaucoma (POAG) is highest among racial/ethnic minority groups, particularly Black individuals. The prevalence of POAG worldwide is projected to increase from 52.7 million in 2020 to 79.8 million in 2040, a 51.4% increase attributed mainly to Asian and African individuals. Given this increase, key stakeholders need to pay particular attention to creating a diverse study population in POAG clinical trials.ObjectiveTo assess the prevalence of racial/ethnic minorities in POAG clinical research trials compared with White individuals.Data sourcesThis meta-analysis consisted of publicly available POAG clinical trials using ClinicalTrials.gov, PubMed, and Drugs@FDA from 1994 to 2019.Study selectionRandomized clinical trials that reported on interventions for POAG and included demographic subgroups including sex and race/ethnicity.Data extraction and synthesisUsing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, 2 independent reviewers extracted study-level data for a random-effects meta-analysis. A third person served as the tiebreaker on study selection. Microsoft Excel 2016 (Microsoft Corporation) and SAS, version 9.4 (SAS Institute) were used for data collection and analyses.Main outcomes and measuresThe primary outcomes were the prevalence of each demographic subgroup (White, Black, Hispanic/Latino, other race/ethnicity groups, and female or male) in each trial according to the trial start year, study region, and study sponsor. Participation rates are expressed as percentages.ResultsA total of 105 clinical trials were included in the meta-analysis, including 33 428 POAG clinical trial participants (18 404 women [55.1%]). Overall, 70.7% were White patients, 16.8% were Black patients, 3.4% were Hispanic/Latino patients, and 9.1% were individuals of other races/ethnicities, including Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native, and unreported as defined by the US Census. The mean (SD) numbers of participants by race/ethnicity were 236.5 (208.2) for White, 58.4 (70.0) for Black, 29.9 (71.1) for Hispanic/Latino, and 31.1 (94.3) for other race/ethnicity. According to the test for heterogeneity using the Cochrane Risk of Bias tool, the I2 statistic was 98%, indicating high heterogeneity of outcomes in the included trials. A multiple linear regression analysis was performed to assess any trend and significance between participation by Black individuals and the year the study started, the region in which the study took place, and the study sponsor. There was no significant increase of Black participant enrollment from 1994 to 2019 (r2 = 0.11; P = .17) and no significant association between Black participant enrollment and clinical trial region (r2 = 0.16; P = .50), but there was a significant association between Black participant enrollment and study sponsor (r2 = 0.94; P = .03).Conclusions and relevanceThis meta-analysis found that compared with White individuals, individuals from racial/ethnic minority groups had a very low participation rate in POAG clinical trials despite having a higher prevalence among the disease population. Despite measures to increase clinical trial diversity, there has not been a significant increase in clinical trial participation among Black individuals, the group most affected by this disease; this disparity in POAG clinical trial representation can raise questions about the true safety and efficacy of approved medical interventions for this disease and should prompt further research on how to increase POAG clinical trial diversity.
| S-EPMC8132140 | biostudies-literature