Adequacy of reporting race/ethnicity in clinical trials in areas of health disparities

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.

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Abstract TP409: Reporting of Key Demographic Characteristics in Neurological Trials Registered on ClinicalTrials.gov

Stroke ◽

10.1161/str.48.suppl_1.tp409 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Kush Fansiwala ◽

Lauren Southwick ◽

Emily Goldmann ◽

Nina S Parikh ◽

Joy Madubuonwu ◽

...

Keyword(s):

Clinical Trials ◽

Race And Ethnicity ◽

Neurological Diseases ◽

Demographic Characteristics ◽

Mandatory Reporting ◽

Trial Participation ◽

Limited Participation ◽

Chi Square ◽

Before And After ◽

Race Ethnicity

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.

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Medical and Social Determinants of Brain Health and Dementia in a Multicultural Community Cohort of Older Adults

Journal of Alzheimer s Disease ◽

10.3233/jad-215020 ◽

2021 ◽

pp. 1-14

Author(s):

James E. Galvin ◽

Stephanie Chrisphonte ◽

Lun-Ching Chang

Keyword(s):

Older Adults ◽

Health Disparities ◽

African Americans ◽

Health Outcomes ◽

Sex Education ◽

Screening Program ◽

Healthcare Services ◽

Social Dimension ◽

Medical Comorbidities ◽

Race Ethnicity

Background: Socioeconomic status (SES), race, ethnicity, and medical comorbidities may contribute to Alzheimer’s disease and related disorders (ADRD) health disparities. Objective: Analyze effects of social and medical determinants on cognition in 374 multicultural older adults participating in a community-based dementia screening program. Methods: We used the Montreal Cognitive Assessment (MoCA) and AD8 as measures of cognition, and a 3-way race/ethnicity variable (White, African American, Hispanic) and SES (Hollingshead index) as predictors. Potential contributors to health disparities included: age, sex, education, total medical comorbidities, health self-ratings, and depression. We applied K-means cluster analyses to study medical and social dimension effects on cognitive outcomes. Results: African Americans and Hispanics had lower SES status and cognitive performance compared with similarly aged Whites. We defined three clusters based on age and SES. Cluster #1 and #3 differed by SES but not age, while cluster #2 was younger with midlevel. Cluster #1 experienced the worse health outcomes while cluster #3 had the best health outcomes. Within each cluster, White participants had higher SES and better health outcomes, African Americans had the worst physical performance, and Hispanics had the most depressive symptoms. In cross-cluster comparisons, higher SES led to better health outcomes for all participants. Conclusion: SES may contribute to disparities in access to healthcare services, while race and ethnicity may contribute to disparities in the quality and extent of services received. Our study highlights the need to critically address potential interactions between race, ethnicity, and SES which may better explain disparities in ADRD health outcomes.

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Race/Ethnicity and the Pharmacogenetics of Reported Suicidality With Efavirenz Among Clinical Trials Participants

The Journal of Infectious Diseases ◽

10.1093/infdis/jix248 ◽

2017 ◽

Vol 216 (5) ◽

pp. 554-564 ◽

Cited By ~ 15

Author(s):

Katie R Mollan ◽

Camlin Tierney ◽

Jacklyn N Hellwege ◽

Joseph J Eron ◽

Michael G Hudgens ◽

...

Keyword(s):

Clinical Trials ◽

Race Ethnicity

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Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials

Future Oncology ◽

10.2217/fon-2020-1262 ◽

2021 ◽

Author(s):

D Ross Camidge ◽

Haeseong Park ◽

Karen E Smoyer ◽

Ira Jacobs ◽

Lauren J Lee ◽

...

Keyword(s):

Clinical Trials ◽

Phase I ◽

Predominantly White ◽

Race And Ethnicity ◽

Phase I Trials ◽

Minimal Representation ◽

Phase I Clinical Trials ◽

Demographic Representation ◽

The Usa ◽

Race Ethnicity

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

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“Centering the Margins”: Moving Equity to the Center of Men’s Health Research

American Journal of Men s Health ◽

10.1177/1557988318773973 ◽

2018 ◽

Vol 12 (5) ◽

pp. 1317-1327 ◽

Cited By ~ 6

Author(s):

Derek M. Griffith

Keyword(s):

Health Disparities ◽

Health Equity ◽

Men’S Health ◽

Men's Health ◽

Men Of Color ◽

Equity Research ◽

Health Equity Research ◽

Health Progress ◽

Race Ethnicity ◽

Primary Focus

How might the science of men’s health progress if research on marginalized or subordinated men is moved from the margins of the literature to the center? This commentary seeks to answer this question, suggesting that if more attention is paid to men of color and other marginalized men, the field will be greatly enriched in its ability to understand determinants of men’s health. Reimagining men’s health by moving men’s health disparities to a primary focus of the field may yield critical new insights that would be essential to moving men’s health to the center of health equity research. Focusing on the dual goals of improving the health of marginalized men and examining the determinants of disparities among men and between men and women will yield insights into mechanisms, pathways, and strategies to improve men’s health and address health disparities. Current definitions of health disparities limit the nation’s ability to dedicate resources to populations that need attention—men of color and other marginalized men—that do not fit these definitions. Moving marginalized men to the center of research in men’s health will foster new ways of understanding determinants of men’s health that cannot be identified without focusing on populations of men whose health is as influenced by race, ethnicity, and other structures of marginalization as it is by gender and masculinities. Using Black men as a case example, the article illustrates how studying marginalized men can refine the study of men’s health and health equity.

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