Disparities in reporting and representation of women, older adults and racial minorities in immune checkpoint inhibitor (ICI) clinical trials.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6549-6549
Author(s):  
Irbaz Bin Riaz ◽  
Mahnoor Islam ◽  
Ahsan Masood Khan ◽  
Syed Arsalan Ahmed Naqvi ◽  
Rabbia Siddiqi ◽  
...  

6549 Background: Representation and outcomes of women, older adults, and racial minorities in ICI trials has not been previously described. Methods: MEDLINE and Embase were searched to identify ICI RCTs. Data for trial characteristics, proportion of trials reporting race, age and sex as well as the proportion of patients by race, age and sex enrolled in ICI trials was collected. Descriptive statistics were reported for trials reporting minority representation and proportion of included patients by race, age and sex. Disparities in representation were calculated using enrollment incidence disparity (EID) and enrollment incidence ratios (EIR) by comparing trial enrollment against U.S. population-based estimates acquired from the SEER 18 incidence database. The relationship of EID to key trial characteristics were compared using standard parametric and non-parametric statistical tests. Trends in EIR were analyzed using the Joinpoint Regression Analysis software. Results: 108 ICI trials from 2009 to 2020 with 48,360 patients were included in this analysis. All RCTs reported sex (101/101). 78 trials reported race (72%), of which only 41 trials (38%) reported data on all 5 U.S. racial categories (Black, White, Asian, Pacific Islander and Native American). Participation of Black patients was reported in 66 trials (61%), White participants in 78 trials (72%), Asians in 69 trials (64%), Native Americans and Pacific Islanders in 41 trials (38%), and Hispanics in 24 trials (22%). Age categories were inconsistently defined, and 80 trials (74%) reported the proportion of patient by age categories. Subgroup analyses of clinical outcomes by race, age and sex were reported in 17 (22%), 62 (79%) and 57 (73%) trials respectively. Women (trial proportion [TP]: 32%; EIR: 0.77), patients aged ≥ 65 years (TP: 42%; EIR: 0.74), Black participants (TP: 1.8%; EIR: 0.17) and Hispanic participants (TP: 5.9%; EIR: 0.67) were largely underrepresented, and Asians were overrepresented (TP: 15.9%; EIR: 2.64). Black patients were underrepresented across all cancer types. Similarly, women, older adults ( > 65 years of age) and Hispanic patients were consistently underrepresented across cancer types with few exceptions. Representation of older adults increased significantly from 2010-2020 (APC: 2.72), while representation of Black patients decreased significantly from 2009-2020 (APC: -23.37). Black patients were found to be significantly underrepresented in phase III trials (p = 0.0005), trials with OS as the primary endpoint (p = 0.004), and PD1 inhibitor trials (p = 0.002). Hispanics were significantly underrepresented in PD1 inhibitor trials (p = 0.003). Conclusions: There is both suboptimal reporting about participation and underrepresentation of women, racial minorities (particularly Black patients) and older adults in ICI trials as compared to their cancer incidence.

Author(s):  
Roli Varma ◽  
Vanessa Galindo-Sanchez

In the 1990s, a number of efforts had been made to increase the representation of women in computer science (CS) and computer engineering (CE) education, mostly to compensate for the expected shortfall of candidates from the traditional source: 18-year-old non-Hispanic white males. Yet, women remain underrepresented in the CS and CE disciplines. The underrepresentation of minority women is especially conspicuous and is absolutely glaring among Native American women. Though there are studies on the underrepresentation of women in CS and CE education, there are very few studies on minority women, and there is very little scholarly work on Native American women. Because Native Americans—officially classified as American Indians and/or Alaska Natives—are relatively small in number (1.5% of the U.S. population), they are seldom represented in assessments of gender and/or racial disparities in CS and CE education. The educational attainment levels of Native American women have improved significantly over the last two decades. Despite these advances, the education level of Native American women remains considerably below the levels of the total population. They are less likely than the total population to graduate from high school, to enroll in college, and to graduate from college (Madrid, 1997). Native American women who do enroll in and graduate from college are less likely to be in science or engineering disciplines. Native American women who do graduate in science or engineering disciplines are less likely to be in CS or CE. For instance, in 2001, Native Americans earned only 271 bachelor’s degrees in CS. Of these, Native American men earned 193 and women earned 78. Of incoming freshmen in 2002, only 4% of Native American men and 0.5% of Native American women intended to major in CS (National Science Foundation [NSF], 2004). This article discusses why so few Native American women pursue education in CS or CE disciplines after high school.


2015 ◽  
Author(s):  
Caitlin McHugh ◽  
Timothy A Thornton ◽  
Lisa Brown

The genetic structure of human populations is often characterized by aggregating measures of ancestry across the autosomal chromosomes. While it may be reasonable to assume that population structure patterns are similar genome-wide in relatively homogeneous populations, this assumption may not be appropriate for admixed populations, such as Hispanics and African Americans, with recent ancestry from two or more continents. Recent studies have suggested that systematic ancestry differences can arise at genomic locations in admixed populations as a result of selection and non-random mating. Here, we propose a method, which we refer to as the chromosomal ancestry differences (CAnD) test, for detecting heterogeneity in population structure across the genome. CAnD uses local ancestry inferred from SNP genotype data to identify chromosomes harboring genomic regions with ancestry contributions that are significantly different than expected. In simulation studies with real genotype data from Phase III of the HapMap Project, we demonstrate the validity and power of CAnD. We apply CAnD to the HapMap Mexican American (MXL) and African American (ASW) population samples; in this analysis the software RFMix is used to infer local ancestry at genomic regions assuming admixing from Europeans, West Africans, and Native Americans. The CAnD test provides strong evidence of heterogeneity in population structure across the genome in the MXL sample ($p=4e-05$), which is largely driven by elevated Native American ancestry and deficit of European ancestry on the X chromosomes. Among the ASW, all chromosomes are largely African derived and no heterogeneity in population structure is detected in this sample.


2020 ◽  
Vol 4 (4) ◽  
Author(s):  
Joseph M Unger ◽  
Dawn L Hershman ◽  
Raymond U Osarogiagbon ◽  
Anirudh Gothwal ◽  
Seerat Anand ◽  
...  

Abstract Background Many clinical trials supporting new drug applications underrepresent minority patients. Trials conducted by the National Cancer Institute’s National Clinical Trial’s Network (NCTN) have greater outreach to community sites, potentially allowing better representation. We compared the representation of Black patients in pharmaceutical company–sponsored cancer clinical trials with NCTN trials and with the US cancer population. Methods We established a large cohort of study publications representing the results of trials that supported new US Food and Drug Administration drug approvals from 2008 to 2018. NCTN trial data were from the SWOG Cancer Research Network. US cancer population rates were estimated using Surveillance, Epidemiology, and End Results survey data. We compared the proportion of Black patients by enrollment year for each cancer type and overall. Tests of proportions were used. All statistical tests were 2-sided. Results A total 358 trials (pharmaceutical company–sponsored trials, 85; SWOG trials, 273) comprised of 93 825 patients (pharmaceutical company–sponsored trials, 46 313; SWOG trials, 47 512) for 15 cancer types were analyzed. Overall, the proportion of Black patients was 2.9% for pharmaceutical company–sponsored trials, 9.0% for SWOG trials, and 12.1% for the US cancer population (P < .001 for each pairwise comparison). These findings were generally consistent across individual cancer types. Conclusions The poor representation of Black patients in pharmaceutical company–sponsored trials supporting new drug applications could result in the use of new drugs with little data about efficacy or side effects in this key population. Moreover, because pharmaceutical company–sponsored trials test the newest available therapies, limited access to these trials represents a disparity in access to potential breakthrough therapies.


2011 ◽  
Author(s):  
Elizabeth Focella ◽  
Jessica Whitehead ◽  
Jeff Stone ◽  
Stephanie Fryberg ◽  
Rebecca Covarrubias

2019 ◽  
Vol 42 (2) ◽  
pp. 32-39
Author(s):  
LaNada War Jack

The author reflects on her personal experience as a Native American at UC Berkeley in the 1960s as well as on her activism and important leadership roles in the 1969 Third World Liberation Front student strike, which had as its goal the creation of an interdisciplinary Third World College at the university.


2018 ◽  
Vol 6 (9) ◽  
pp. 5
Author(s):  
Poonam Chourey

The research expounded the turmoil, uproar, anguish, pain, and agony faced by native Indians and Native Americans in the South Dakota region.  To explain the grief, pain and lamentation, this research studies the works of Elizabeth Cook-Lyn.  She laments for the people who died and also survived in the Wounded Knee Massacre.  The people at that time went through huge exploitation and tolerated the cruelty of American Federal government. This research brings out the unchangeable scenario of the Native Americans and Native Indians.  Mr. Padmanaban shed light on the works of Elizabeth Cook-Lynn who was activist.  Mr. Padmanaban is very influenced with Elizabeth Cook-Lynn’s thoughts and works. She hails from Sioux Community, a Native American.  She was an outstanding and exceptional scholar.  She experienced the agony and pain faced by the native people.  The researcher, Mr. Padmanaban is concerned the sufferings, agony, pain faced by the South Dakota people at that time.  The researcher also is acknowledging the Indian freedom fighters who got India independence after over 200 years of sufferings.  The foreign nationals entered our country with the sole purpose of business.  Slowly and steadily the took over the reign of the country and ruled us for years, made all of us suffer a lot.


Genetics ◽  
2001 ◽  
Vol 158 (3) ◽  
pp. 941-948
Author(s):  
Linda Burhansstipanov ◽  
Lynne Bemis ◽  
Mark Dignan ◽  
Frank Dukepoo

Abstract The long-term goal of Genetic Education for Native Americans (GENA), a project funded by the National Human Genome Research Institute (NHGRI), is to provide a balance of scientific and cultural information about genetics and genetic research to Native Americans and thereby to improve informed decision making. The project provides culturally sensitive education about genetic research to Native American medical students and college and university students. Curriculum development included focus groups, extensive review of available curricula, and collection of information about career opportunities in genetics. Special attention was focused on genetic research to identify key concepts, instructional methods, and issues that are potentially troublesome or sensitive for Native Americans. Content on genetic research and careers in genetics was adapted from a wide variety of sources for use in the curriculum. The resulting GENA curriculum is based on 24 objectives arranged into modules customized for selected science-related conference participants. The curriculum was pretested with Native American students, medical and general university, health care professionals, and basic scientists. Implementation of the curriculum is ongoing. This article describes the development and pretesting of the genetics curriculum for the project with the expectation that the curriculum will be useful for genetics educators working in diverse settings.


2021 ◽  
pp. 1-18
Author(s):  
Raymond Foxworth ◽  
Laura E. Evans ◽  
Gabriel R. Sanchez ◽  
Cheryl Ellenwood ◽  
Carmela M. Roybal

We draw on new and original data to examine both partisan and systemic inequities that have fueled the spread of COVID-19 in Native America. We show how continued political marginalization of Native Americans has compounded longstanding inequalities and endangered the lives of Native peoples. Native nations have experienced disproportionate effects from prior health epidemics and pandemics, and in 2020, Native communities have seen greater rates of infection, hospitalization, and death from COVID-19. We find that Native nations have more COVID-19 cases if they are located in states with a higher ratio of Trump supporters and reside in states with Republican governors. Where there is longstanding marginalization, measured by lack of clean water on tribal lands and health information in Native languages, we find more COVID-19 cases. Federal law enables non-members to flout tribal health regulations while on tribal lands, and correspondingly, we find that COVID-19 cases rise when non-members travel onto tribal lands. Our findings engage the literatures on Native American politics, health policy within U.S. federalism, and structural health inequalities, and should be of interest to both scholars and practitioners interested in understanding COVID-19 outcomes across Tribes in the United States.


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