scholarly journals The Underrepresentation of Minorities and Non-Generalizability of Breast Cancer Clinical Trials?

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
Breast Cancer ◽  
United States ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Minority Groups ◽  
The United States ◽  
Cancer Clinical Trials ◽  
High Death

Introduction This year 43,000 women will die from breast cancer in the United States. African Americans and Native Americans though less likely to get breast cancer, once diagnosed they are much more likely to die from breast cancer. This increased death rate may in part be due to the non-generalizability of breast cancer clinical trials. In this study, we evaluate the participation of ethnic minorities from breast cancer clinical trials. Methodology In this study, fifty-six breast cancer clinical trials completed in the last ten years in the United States were evaluated for the inclusion of ethnic minorities in the breast cancer clinical trials. Results Only 21% of breast cancer clinical trials include information on ethnicity in the methodology while only 7% provided any information on the effect or toxicity of the therapeutic intervention in minority groups while 100% report the results for Whites. Though Whites only make up 60.1% of the population, they were 87.5% of the clinical trial participants while African Americans were 6.2%, Hispanics 3.1%, Asians 2.9% and Native Americans were 0.2% of the participants. Conclusion Racial minorities have been underrepresented in breast cancer clinical trials which may contribute to unnecessarily high death rates in these groups while suggesting limited generalizability of breast cancer clinical trials.

scholarly journals The Systemic Exclusion of Native Americans from Cancer Clinical Trials.

2021 ◽  
Author(s):  
Joseph Angel De Soto ◽  
Gabriel Selassie ◽  
Gilberta Yazzie
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Native American ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Health Care Disparities ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Unnecessary Death

Introduction: A major source of health care disparities derives from the underrepresentation of ethnic minorities in clinical trials. The inclusion of ethnic minorities is necessary to generalize the results in terms of efficacy and toxicology of medications in cancer treatment. Methodology: In this retrospective study, 80 cancer clinical trials with an aggregate of 278,470 participants performed within the last ten years were selected at random. The number of ethnic minorities participating and inclusion of them in the results were evaluated. Results: Only, 42.5% of cancer clinical trials reported the ethnic background of participants in their trials while even less 5% reported the efficacy or toxicology of the therapeutic intervention for ethnic minorities. Whites, Hispanics, African Americans, and Native Americans make up 60.1%, 18.5%, 13.4% and 1.5% of the population they made up 85.3%, 2.54%, 7.6% and 0.12% of the participants that reported ethnicity, respectively. Out of 278,470 participants in cancer clinicals trials only 133 (0.048%) could be identified as Native American . Conclusion: Native Americans were nearly completely excluded from cancer clinical trials. African Americans and Hispanics were greatly underrepresented. Cancer Clinical trials may not be generalizable and have been inherently racist in the United States. This has led to the unnecessary death and suffering of Native Americans from cancer.

scholarly journals Colon Cancer: The Exclusion of Native Americans and Hispanics from Clinical Trials in the United States

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Colon Cancer ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
The United States ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Trial Participants

Abstract:Introduction: Each year there are 150,000 new cases of colon cancer in the United States. The chance of death for Hispanics and Native Americans who get colon cancer is much higher than whites even though both groups are much less likely to get colon cancer than whites. In this study, we look at the inclusion or exclusion of Hispanics and Native Americans from colon cancer clinical trials. Methods: In this retrospective study, 48 colon cancer clinical trials in the United States with an aggregate of 421,530 participants performed within the last ten years were selected at random. These clinical trials were evaluated for the inclusion and exclusion of minorities. Results: Though whites make up only 60.1% of the population they make up 89% of the colon cancer clinical trial participants. African Americans, and Hispanics who make up 13.4% and 18.5% of the population only made up 5.6% and 0.6% of the colon cancer clinical trial participants. Only two native Americans out of 421,530 colon cancer clinical trial participants could be identified. Conclusion: Colon Cancer Clinical trials have systematically excluded Hispanics and Native Americans while minimizing the participation of African Americans. This may be directly related to the increased death rates seen in these groups and provides evidence for the non-generalizability of colon cancer clinical trials.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

Racial Sentiment and Public Support for Arming Teachers with Guns in the United States

2021 ◽  
pp. 215336872110389
Author(s):  
Andrew J. Baranauskas
Keyword(s):  
United States ◽  
African Americans ◽  
Minority Groups ◽  
Public Support ◽  
The United States ◽  
Data Set ◽  
Racial Issue ◽  
Racial Resentment ◽  
Nationally Representative ◽  
Negative Feelings

In the effort to prevent school shootings in the United States, policies that aim to arm teachers with guns have received considerable attention. Recent research on public support for these policies finds that African Americans are substantially less likely to support them, indicating that support for arming teachers is a racial issue. Given the racialized nature of support for punitive crime policies in the United States, it is possible that racial sentiment shapes support for arming teachers as well. This study aims to determine the association between two types of racial sentiment—explicit negative feelings toward racial/ethnic minority groups and racial resentment—and support for arming teachers using a nationally representative data set. While explicit negative feelings toward African Americans and Hispanics are not associated with support for arming teachers, those with racial resentments are significantly more likely to support arming teachers. Racial resentment also weakens the effect of other variables found to be associated with support for arming teachers, including conservative ideology and economic pessimism. Implications for policy and research are discussed.

scholarly journals Epidemiology and Factors Affecting Mortality of Hospitalized Patients with Disseminated Intravascular Coagulation in the United States

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2404-2404
Author(s):  
Arya Mariam Roy ◽  
Manojna Konda ◽  
Akshay Goel ◽  
Appalanaidu Sasapu
Keyword(s):  
United States ◽  
African Americans ◽  
Native Americans ◽  
Mortality Rate ◽  
Length Of Stay ◽  
Disseminated Intravascular Coagulation ◽  
The United States ◽  
Hospitalized Patients ◽  
Northeast Region ◽  
Intravascular Coagulation

Introduction Disseminated Intravascular Coagulation (DIC) is a systemic coagulopathy which leads to widespread thrombosis and hemorrhage and ultimately results in multiorgan dysfunction. DIC usually occurs as a complication of illnesses like severe sepsis, malignancies, trauma, acute pancreatitis, burns, and obstetrical complications. The prognosis and mortality of DIC depend on the etiology, however, the mortality of DIC is known to be on the higher side. The aim of the study is to analyze if gender, race, regional differences have any association with the mortality of hospitalized patients with DIC. Method The National Inpatient Sample database from the Healthcare Cost and Utilization Project (HCUP) for the year 2016 was queried for data. We identified hospital admissions for DIC with the International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis code D65. The data was analyzed with STATA 16.0 version and univariate and multivariate analysis were performed. We studied the characteristics of all such hospitalizations for the year 2016 and the factors associated with the in-hospital mortality rate (MR) of DIC. We used length of stay, cost of stay as an outcome to determine if gender, race, and location play a role in the mortality. Results A total of 8704 admissions were identified with a diagnosis of DIC during the year 2016. The mean age for admission was found to be 56.48± 0.22. The percentage of admissions in females and males did not have a notable difference (50.57% vs 49.43%). The disease specific MR for DIC was 47.7%. Admission during weekend vs weekdays did not carry a statistically significant difference in terms of MR. Females with DIC were less likely to die in the hospital when compared to males with DIC (OR= 0.906, CI 0.82 - 0.99, p= 0.031). Interestingly, African Americans (AA) with DIC admissions were found to have 24% more risk of dying when compared to Caucasians admitted with DIC (OR= 1.24, CI 1.10 - 1.39, P= 0.00), Native Americans (NA) has 67% more risk of dying when compared to Caucasians (OR= 1.67, CI 1.03 - 2.69, p= 0.035). The mortality rate of NA, AA, Caucasians with DIC was found to be 57%, 52%, 47% respectively. The MR was found to be highest in hospitals of the northeast region (52%), then hospitals in the south (47%), followed by west and mid-west (46%), p= 0.000. Patients admitted to west and mid-west were 24% less likely to die when compared to patients admitted to northeast region hospitals (OR= 0.76, p= 0.001). The average length of stay and cost of stay were also less in west and mid-west regions when compared to north east. The difference in outcomes persisted after adjusting for age, gender, race, hospital division, co-morbid conditions. Conclusion Our study demonstrated that African Americans and Native Americans with DIC have high risk of dying in the hospital. Also, there exists a difference between the mortality rate, length and cost of stay among different regions in the United States. More research is needed to elucidate the factors that might be impacting the location-based variation in mortality. Disclosures No relevant conflicts of interest to declare.

Poor Survival for US Pacific Islander Cancer Patients: Evidence From the Surveillance, Epidemiology, and End Results Database: 1991 to 2004

2007 ◽  
Vol 25 (36) ◽  
pp. 5738-5741 ◽  
Author(s):  
William B. Goggins ◽  
Grace K.C. Wong
Keyword(s):  
United States ◽  
African Americans ◽  
Native Americans ◽  
Cancer Survival ◽  
The United States ◽  
Native Hawaiians ◽  
Targeted Interventions ◽  
Female Breast ◽  
Cause Specific Survival ◽  
End Results

Purpose Although racial and ethnic differences in cancer survival in the United States have been studied extensively, little is known about cancer survival in US Pacific Islanders (PIs), a fast-growing and economically disadvantaged minority group. Methods Using data from the US National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) registries, we compared cause-specific and all-cause survival for female breast, prostate, lung, colorectal, stomach and liver cancer for Native Hawaiians, Samoans, other PIs (including Tongans, Guamanians, and others), African Americans, and Native Americans with non-Hispanic whites using Cox proportional hazards models. Separate models were fitted adjusting for demographic factors only and demographic and disease severity variables. Results Among all groups, Samoans were the most likely to present with advanced disease and had the worst cause-specific survival for all sites considered. Samoans had particularly poor results (adjusted for demographic variables only) for female breast (relative risk [RR] = 3.05; 95% CI, 2.31 to 4.02), colorectal (RR = 1.82; 95% CI, 1.37 to 2.41) and prostate (RR = 4.82; 95% CI, 3.38 to 6.88) cancers. Native Hawaiians and other PIs also had significantly worse cause-specific survival than did non-Hispanic whites for most sites, but generally had better survival than African Americans or Native Americans. Conclusion Much of the survival disadvantage for PI groups appears to be a result of late diagnosis, and thus targeted interventions have much potential to reduce cancer mortality in this group. More research is needed to find explanations for the particularly poor cancer survival for Samoans in the United States.

Interactions with Asians in Higher Education: Beyond Multicultural Myths

2019 ◽  
Vol 14 (2) ◽  
Author(s):  
Festus E. Obiakor
Keyword(s):  
Higher Education ◽  
United States ◽  
African Americans ◽  
Native Americans ◽  
Linguistically Diverse ◽  
The United States ◽  
Culturally And Linguistically Diverse ◽  
Model Minorities ◽  
Critical Issues ◽  
Education Today

AbstractOne of the critical issues in education today is how to help all students to maximize their fullest potential. Achieving this goal seems to be difficult for many people who come from culturally and linguistically diverse (CLD) backgrounds. At all levels, they endure direct and indirect disenfranchisements, disadvantages, and disillusionments, especially if they learn differently, are racially different, demonstrate different behavioral patterns, have different personal idiosyncrasies, or come from different countries. Despite these apparent impediments, Asians are viewed by many as “model” minorities when compared to African Americans, Latinos, and Native Americans. This view has continued to affect how Asians view themselves and how the society as a whole views them. Coming originally from Nigeria to the United States, I have had myriad interactions with Asians as student, professor, scholar, leader, and professional. In this article, I share my experiences with Asians and how these experiences have exposed multicultural realities and myths.

Analysis of cancer clinical trials in the United States with comparison of National Institute of Health (NIH) and pharmaceutical industry (PHARMA)-sponsored studies.

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 6084-6084 ◽  
Author(s):  
K. R. Oettel ◽  
N. R. Ruther ◽  
M. A. Mathiason ◽  
J. K. Keller ◽  
J. E. Schroeder ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
The United States ◽  
Cancer Clinical Trials

Forgiveness: An Interview

PMLA ◽  
2002 ◽  
Vol 117 (2) ◽  
pp. 278-295 ◽  
Author(s):  
Julia Kristeva ◽  
Alison Rice
Keyword(s):  
United States ◽  
South Africa ◽  
African Americans ◽  
Native Americans ◽  
The United States ◽  
Julia Kristeva ◽  
Japanese Americans ◽  
The Holocaust ◽  
Aboriginal Children

This interview with julia kristeva, conducted on 25 april 2000, focuses on forgiveness, a topic that is receiving considerable attention worldwide. Numerous nations around the globe have recently extended apologies to specific groups of people, including South Africa, to victims of apartheid; Britain, to the Maori people; Australia, to stolen aboriginal children; the United States, to Native Americans, Japanese Americans, and African Americans; and Germany, to victims of the Holocaust. This remarkable international proliferation of requests for forgiveness for wrongdoing and of attempts to make amends has not escaped the attention of prominent literary critics and philosophers.

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