scholarly journals Racial and Ethnic Enrollment Disparities and Demographic Reporting Requirements in Acute Leukemia Clinical Trials

Author(s):  
Andrew Hantel ◽  
Marlise R. Luskin ◽  
Jacqueline S Garcia ◽  
Wendy Stock ◽  
Daniel J DeAngelo ◽  
...  

Data regarding racial and ethnic enrollment diversity for acute myeloid (AML) and lymphoid leukemia (ALL) clinical trials in the United States (US) 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 US ALL and AML trials from 2002-2017 as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML and 97 ALL trials with results, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML N=6,554; ALL N=4,149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared to NH-white patients after adjusting for race-ethnic disease incidence (AML odds: 0.68, 0.31, 0.75, and 0.83; ALL: 0.74, 0.27, 0.67, and 0.64; all p≤0.01). The proportion of trials reporting race increased significantly after the reporting requirements (44.2 to 60.2%; p=0.02), but race-ethnicity reporting did not (34.8 to 38.6%; p=0.57). Reporting proportions by number of patients enrolled increased significantly after the reporting requirements (race: 51.7 to 72.7%, race-ethnicity: 39.5 to 45.4%; both p<0.001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds: 0.79 and 0.77; ALL: 0.35 and 0.25; both p≤0.01). 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.

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2101-2101
Author(s):  
Manali I. Patel ◽  
Norman Johnson ◽  
Sean Altekruse ◽  
Kim Rhoads

Abstract Background: Previously, we demonstrated mortality disparities for minorities with Acute Leukemia (AL) despite favorable demographic and genetic prognostic factors. We also showed that differences in treatment by race/ethnicity explained a large component of this disparity. However, due to the limitations of the Surveillance Epidemiology and End Results (SEER) stand-alone database, we could not explore the association between AL mortality and socioeconomic status (SES) factors. The purpose of the current study is to determine how SES impacts racial/ethnic differences in AL mortality using an expanded SEER-SES linked dataset. Because SES may influence the receipt of high quality care, we hypothesize that SES factors will explain some proportion of AL mortality disparities. Methods: Patients with acute lymphocytic (ALL) and acute myeloid (AML) leukemia were identified in SEER and linked to the National Longitudinal Mortality Study (NLMS). The NLMS contains patient-level SES factors collected by in-person and telephone interview surveys for a random sample in the United States Census Bureau Current Population Surveys (CPS) from the years 1979 to 2011. The SEER-NLMS linkage includes detailed cancer information (date of diagnosis, type of cancer, cause of death) and detailed SES factors (marital status, education, income, home ownership, occupation, insurance status) as well as individual demographic factors (age, gender, race/ethnicity). Cox proportional hazard models were built to estimate the hazard of mortality by race/ethnicity after consideration of individual, clinical, and SES factors. Results: A total of 621 patients were diagnosed with ALL and AML during the study period. Thirty-six records were excluded due to missing data leaving 124 (21%) patients with ALL and 461 (79%) with AML in the analysis. ALL: The majority of patients were non-Hispanic white (NHW) (n=73; 59%), followed by Hispanic (n=22; 18%), Asian Pacific Islander (API) (n=8; 6%), non-Hispanic black (NHB) (n=8; 6%) and unspecified/other race (n=13; 10%). Hispanic patients had a 3-fold increase in the hazard of death (HR 3.21; 95% CI (2.00-5.17)) when compared to NHW patients. Education and income decreased the hazard of death for Hispanic compared to NHW patients (HR 2.33 95% CI (1.21-4.48)). Insurance status further reduced this disparity (HR 2.02 95% CI (1.01-4.04)). Further adjustment for occupation and household ownership completely neutralized these disparities (HR 1.14; 95% CI (0.52-2.41)). AML: The sample included 67% NHW (n=311) patients; 7% Hispanic (n =31), 5% NHB (n=22), 6% API (n=29) and 15% patients with unspecified/other race (n=68). Similar to ALL, there was a significant association between Hispanic ethnicity and increase hazard of mortality (HR 1.50; 95% CI (1.06-2.11)). There was a marked decreased hazard of mortality associated with API (HR 0.64 95% CI (0.44-0.91)) compared with NHW patients. The results in models adjusted for select SES factors demonstrated a persistent, unchanged mortality disparity for Hispanic patients. Conclusions: SES factors explain some proportion of disparities in acute leukemia mortality, with the most impact in ALL; however, SES factors do not have as strong of an association in AML. Future interventions should be attentive to the underlying and specific factors that can reduce disparities in these diseases. Disclosures No relevant conflicts of interest to declare.


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 311-311
Author(s):  
Wilson I. Gonsalves ◽  
Adam C Bartley ◽  
Ronald S. Go

311 Background: Previous population-based studies have shown variations in disease incidence and overall survival (OS) among multiple myeloma (MM) patients (pts) from different ethnic and racial backgrounds. However, the impact of race and ethnicity on early mortality (EM) or death in the first year after the diagnosis of MM is less well known. Methods: Pts with MM diagnosed from 2000-2011 were identified in the NCDB. We obtained data associated with socio-demographics, type and location of care facility, as well as the use of autologous stem cell transplant (ASCT) as an initial treatment option. Two cohorts were created based on the use of ASCT: 1) The group who received an upfront ASCT and 2) Pts who were 75 years or older who are unlikely to have ever received an ASCT. The rate of early mortality (EM) was estimated using the 1-year OS and assessed for all pts based on racial/ethnic background and the use of ASCT in their therapy. Results: There were a total of 108,352 pts who were included in this analysis. The median age of this cohort was 65 years (Range: 20 – 90). Of these 58,223 (54%) were male. The racial distributions of these cohorts were as follows: 78,589 (73%) White non-Hispanic (WNH), 21,292 (20%) Black non-Hispanic (BNH), 1,943 (2%) Asian Pacific-Islander (API), 293 (< 1%) Native-American (NA) and 6,235 (5%) Hispanics-any race (HIS). The estimated 1-yr OS (95% CI) was 71% (71 – 72) for WNH, 74% (73 – 74) for BNH, 77% (75 – 79) for API, 73% (68 – 78) for NA and 75% (74 – 76) for HIS. Amongst patients who received an upfront ASCT, the estimated 1-yr OS (95% CI) was 97% (97 – 98) for WNH (Reference), 98% (97 – 98) for BNH (P = 0.99), 99% (99 – 100) for API (P = 0.96) and 98% (97 – 99) for HIS (P = 0.99). Whereas amongst pts who likely never received an ASCT (75 years or older), the estimated 1-yr OS (95% CI) was 55% (54 – 56) WNH (Reference), 57% (56 – 59) for BNH (P = 0.03), 62% (58 – 67) for API (P = 0.02), 55% (43 – 72) for NA (P = 0.99) and 55% (52 – 58) for HIS (P = 0.99). Conclusions: In general, WNHs have a worse 1-yr OS compared to BNH and API. However, this disparity appears significant only among pts unlikely to get an ASCT. Further studies are required to identify explanations for such disparate outcomes based on race and use of ASCT.


BMC Biology ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Shashwat Deepali Nagar ◽  
Andrew B. Conley ◽  
I. King Jordan

Abstract Background Pharmacogenomic (PGx) variants mediate how individuals respond to medication, and response differences among racial/ethnic groups have been attributed to patterns of PGx diversity. We hypothesized that genetic ancestry (GA) would provide higher resolution for stratifying PGx risk, since it serves as a more reliable surrogate for genetic diversity than self-identified race/ethnicity (SIRE), which includes a substantial social component. We analyzed a cohort of 8628 individuals from the United States (US), for whom we had both SIRE information and whole genome genotypes, with a focus on the three largest SIRE groups in the US: White, Black (African-American), and Hispanic (Latino). Our approach to the question of PGx risk stratification entailed the integration of two distinct methodologies: population genetics and evidence-based medicine. This integrated approach allowed us to consider the clinical implications for the observed patterns of PGx variation found within and between population groups. Results Whole genome genotypes were used to characterize individuals’ continental ancestry fractions—European, African, and Native American—and individuals were grouped according to their GA profiles. SIRE and GA groups were found to be highly concordant. Continental ancestry predicts individuals’ SIRE with > 96% accuracy, and accordingly, GA provides only a marginal increase in resolution for PGx risk stratification. In light of the concordance between SIRE and GA, taken together with the fact that information on SIRE is readily available to clinicians, we evaluated PGx variation between SIRE groups to explore the potential clinical utility of race and ethnicity. PGx variants are highly diverged compared to the genomic background; 82 variants show significant frequency differences among SIRE groups, and genome-wide patterns of PGx variation are almost entirely concordant with SIRE. The vast majority of PGx variation is found within rather than between groups, a well-established fact for almost all genetic variants, which is often taken to argue against the clinical utility of population stratification. Nevertheless, analysis of highly differentiated PGx variants illustrates how SIRE partitions PGx variation based on groups’ characteristic ancestry patterns. These cases underscore the extent to which SIRE carries clinically valuable information for stratifying PGx risk among populations, albeit with less utility for predicting individual-level PGx alleles (genotypes), supporting the concept of population pharmacogenomics. Conclusions Perhaps most interestingly, we show that individuals who identify as Black or Hispanic stand to gain far more from the consideration of race/ethnicity in treatment decisions than individuals from the majority White population.


Author(s):  
Edgar Corona ◽  
Liu Yang ◽  
Eric Esrailian ◽  
Kevin A. Ghassemi ◽  
Jeffrey L. Conklin ◽  
...  

Abstract Introduction Esophageal cancer (EC) is an aggressive malignancy with poor prognosis. Mortality and disease stage at diagnosis are important indicators of improvements in cancer prevention and control. We examined United States trends in esophageal adenocarcinoma (EAC) and esophageal squamous cell carcinoma (ESCC) mortality and stage at diagnosis by race and ethnicity. Methods We used Surveillance, Epidemiology, and End Results (SEER) data to identify individuals with histologically confirmed EAC and ESCC between 1 January 1992 and 31 December 2016. For both EAC and ESCC, we calculated age-adjusted mortality and the proportion presenting at each stage by race/ethnicity, sex, and year. We then calculated the annual percent change (APC) in each indicator by race/ethnicity and examined changes over time. Results The study included 19,257 EAC cases and 15,162 ESCC cases. EAC mortality increased significantly overall and in non-Hispanic Whites from 1993 to 2012 and from 1993 to 2010, respectively. EAC mortality continued to rise among non-Hispanic Blacks (NHB) (APC = 1.60, p = 0.01). NHB experienced the fastest decline in ESCC mortality (APC = − 4.53, p < 0.001) yet maintained the highest mortality at the end of the study period. Proportions of late stage disease increased overall by 18.5 and 24.5 percentage points for EAC and ESCC respectively; trends varied by race/ethnicity. Conclusion We found notable differences in trends in EAC and ESCC mortality and stage at diagnosis by race/ethnicity. Stage migration resulting from improvements in diagnosis and treatment may partially explain recent trends in disease stage at diagnosis. Future efforts should identify factors driving current esophageal cancer disparities.


2006 ◽  
Vol 24 (1) ◽  
pp. 141-144 ◽  
Author(s):  
Joseph M. Unger ◽  
Charles A. Coltman ◽  
John J. Crowley ◽  
Laura F. Hutchins ◽  
Silvana Martino ◽  
...  

Purpose A prior analysis by the Southwest Oncology Group (SWOG) showed that women and African American patients were adequately represented on cancer clinical treatment trials but that older patients were substantially underrepresented. Twenty-five percent of patients ≥ 65 years old were enrolled onto SWOG trials from 1993 to 1996, whereas 63% of all patients with cancer were ≥ 65 years old. Recognition of this under-representation led to a change in Medicare policy in 2000 to include coverage of routine patient care costs of clinical trials. We conducted an updated analysis of accrual trends. Methods The proportions of enrollment onto SWOG treatment trials by sex, race/ethnicity, and age (≥ 65 years) were computed for the years 1997 to 2000; corresponding rates in the United States were derived from US Census and National Cancer Institute Surveillance, Epidemiology, and End Results data. Additionally, method of payment data were analyzed over time (1993 to 2003) to assess whether patterns in method of payment changed with the new Year 2000 Medicare policy on clinical trials coverage. Results The results showed continued adequate representation by sex and race/ethnicity. Older patient accrual on SWOG trials increased significantly since 2000, with 31% of patients ≥ 65 years old enrolled from 1997 to 2000 and 38% enrolled from 2001 to 2003 (v 25% from 1993 to 1996). The percentage of patients using Medicare plus supplemental insurance also increased beginning in 2000, whereas the percentage of patients using Medicare alone remained the same. Conclusion Method of payment analyses provided evidence that the Year 2000 Medicare policy change had a positive impact, but only for those patients with supplemental private coverage of coinsurance costs. Improvements in the Medicare payment structure could further increase older patient participation in clinical trials.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kush Fansiwala ◽  
Lauren Southwick ◽  
Emily Goldmann ◽  
Nina S Parikh ◽  
Joy Madubuonwu ◽  
...  

Introduction: To increase the transparency of clinical trial information, U.S. Congress passed the Food and Drug Administration (FDA) Amendments Act of 2007, which expanded prior legislation to mandate inclusion of specific trial characteristics, such as funding source and gender demographics, in a new basic results section on ClinicalTrials.gov. Few studies have examined the extent to which key demographic characteristics such as sex and race/ethnicity are reported for neurological trials on ClinicalTrials.gov. Methods: As part of the National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT), we systematically identified neurological clinical trials on ClinicalTrials.gov (for stroke, epilepsy, Alzheimer’s Disease [AD]) and examined the proportion that reported sex, race, and ethnicity (Hispanic/Latino or not) of study participants. We used the website’s advanced search feature to evaluate demographic information reported from trials conducted between 1999 and 2015. We first calculated frequencies of trials reporting these characteristics, then assessed differences in reporting of each characteristic (yes/no) by condition (stroke, epilepsy, AD) and between trials conducted before and after the basic results section update (pre- and post-2008) using chi-square tests. Results: Our sample comprised 251,847 subjects across 393 trials (147 stroke, 127 epilepsy, 115 AD). Overall, sex was reported for nearly all trials (99.0%), while reporting of race and ethnicity was low (ethnicity: 14.0%, race: 19.8%). Reporting of these characteristics did not differ significantly across the three conditions or between periods preceding and following the FDA act. Conclusion: While ClinicalTrials.gov mandates reporting of sex, it does not require reporting of race/ethnicity, and few trials report these characteristics. This lack of information prevents understanding of neurological trial participation and how interventions might impact patients differently by race/ethnicity. Mandatory reporting of race/ethnicity would enhance transparency and increase awareness of the limited participation of racial/ethnic minorities-who suffer disproportionately from neurological diseases-in neurological trials.


Author(s):  
Jasmine Peters ◽  
Mariel S Bello ◽  
Leigh Spera ◽  
T Justin Gillenwater ◽  
Haig A Yenikomshian

Abstract Racial and ethnic disparities are endemic to the United States and are only beginning to attract the attention of researchers. With an increasingly diverse population, focused and tailored medicine to provide more equitable care is needed. For surgical trauma populations, this topic is a small but expanding field and still rarely mentioned in burn medicine. Disparities in prevention, treatment, and recovery outcomes between different racial and ethnic minorities who are burned are rarely discussed. The purpose of this study is to determine the current status of identified disparities of care in the burn population literature and areas of future research. A systematic review was conducted of literature utilizing PubMed for articles published between 2000-2020. Searches were used to identify articles that crossed the burn term (burn patient OR burn recovery OR burn survivor OR burn care) and a race/ethnicity and insurance status-related term (race/ethnicity OR African-American OR Black OR Asian OR Hispanic OR Latino OR Native American OR Indigenous OR Mixed race OR 2 or more races OR socioeconomic status OR insurance status). Inclusion criteria were English studies in the US that discussed disparities in burn injury outcomes or risk factors associated with race/ethnicity. 1,169 papers were populated, 55 were reviewed, and 36 articles met inclusion criteria. Most studies showed minorities had poorer inpatient and outpatient outcomes. While this is a concerning trend, there is a paucity of literature in this field and more research is needed to create culturally-tailored medical care and address the needs of disadvantaged burn survivors.


2021 ◽  
Author(s):  
D Ross Camidge ◽  
Haeseong Park ◽  
Karen E Smoyer ◽  
Ira Jacobs ◽  
Lauren J Lee ◽  
...  

Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Results: Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African–Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Conclusion: Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups


Assessment ◽  
2021 ◽  
pp. 107319112110386
Author(s):  
Violeta J. Rodriguez ◽  
Dominique L. La Barrie ◽  
Miriam C. Zegarac ◽  
Anne Shaffer

The limited inclusion of racial/ethnic minorities in the development and validation of parenting measures limits our understanding of whether parenting constructs are valid in racial and ethnic minorities. Tests of measurement invariance/equivalence (MI/E) of parenting measures can help evaluate the validity of parenting constructs among racial/ethnic minorities. This systematic review summarized studies on MI/E of parenting constructs by race/ethnicity and evaluated the strength of the evidence. A literature search was conducted using various databases and references to retrieve studies from the United States. Indeed, 10 studies were identified that tested for MI/E of eight parenting scales by race/ethnicity. Only one scale showed moderate evidence of MI/E, five showed weak evidence of MI/E, and two showed no evidence of MI/E. Most studies (80%) used factor analytic methods to test for MI/E, but only two studies (20%) examined all levels of invariance. These findings show that differences exist in how racial/ethnic minorities perceive parenting constructs. Further research is needed to develop more inclusive parenting measures, to protect against the ways in which biased measures may pathologize or misrepresent parenting practices among racial/ethnic minorities.


2019 ◽  
pp. 088626051987602 ◽  
Author(s):  
Wesley M. King ◽  
Arjee Restar ◽  
Don Operario

Intimate partner violence (IPV) is highly prevalent in transgender (trans) populations in the United States; however, details about its manifestations and correlates have not been well captured. Using data from the 2015 U.S. Transgender Survey, we analyzed weighted data from 23,999 adult transgender participants to estimate the prevalence and explore correlates of five IPV subtypes: psychological IPV, physical IPV, trans-related IPV, stalking, and forced sex committed by an intimate partner. Regression models examined race/ethnicity, gender identity, past-year incarceration, past-year sex work, and lifetime homelessness, and adjusted for annual household income, highest level of education, age, birthplace, Census region, and relationship status. The sample was racially/ethnically diverse (62.6% White, 0.7% Alaskan Native/American Indian, 4.7% Asian/Native Hawaiian/Pacific Islander, 12.7% Black/African American, 16.5% Latinx/Hispanic, 0.4% Middle Eastern/North African, 2.5% Multiracial/Not Listed), and comprised of 31.2% transgender men, 34.2% transgender women, 27.5% assigned-female-at-birth nonbinary participants, and 7.1% assigned-male-at-birth nonbinary participants. Rates of IPV were high, with variability by IPV subtype: 42.0% endorsed psychological IPV, 39.9% endorsed physical IPV, 30.4% endorsed trans-related IPV, 18.0% endorsed stalking, and 21.5% endorsed forced sex by an intimate partner. We observed disparities in IPV subtypes by race/ethnicity, gender identity, and experiences of social marginalization. Results highlight the need for targeted, trans-inclusive IPV screening practices and interventions. Future studies should examine the syndemic effects of IPV, social marginalization, and health outcomes related to HIV, substance use, and mental health in trans populations.


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