Abstract 17202: Racial/Ethnic Minority Underreporting and Underrepresentation in Guideline-Driving Blood Cholesterol Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Ashish Sarraju ◽  
Areli Valencia ◽  
Joshua Knowles ◽  
David J Maron ◽  
Fatima Rodriguez
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Census Data ◽  
The United States ◽  
Blood Cholesterol ◽  
Trial Participation ◽  
Atherosclerotic Cardiovascular Disease ◽  
The Us ◽  
Us Census ◽  
Racial Ethnic

Introduction: Cholesterol management is the cornerstone of atherosclerotic cardiovascular disease prevention. Diverse racial/ethnic participation in high-impact cholesterol trials is essential for the generalizability of trials and guidelines across the United States (US). Methods: We analyzed randomized clinical trials (RCTs) cited in the 2018 American Multi-society Guideline on the Management of Blood Cholesterol for reporting and representation of racial/ethnic minorities. We extracted participant level racial/ethnic data, including non-Hispanic White (NHW), Black, Hispanic, or Asian groups. For each race/ethnicity, we pooled trial data to assess overall representation compared to the general US population based on 2010 US Census and 2019 US Census American Community Survey estimates. Results: Among 71 cited RCTs from 1984 - 2017, 59.1% reported racial/ethnic data. NHW participation was reported in 58%, Black in 34%, Hispanic in 27%, and Asian in 17% (Figure). Four trials disaggregated Hispanic patients and none disaggregated Asians. Black trial representation was significantly lower than the US population per 2010 and 2019 Census data (trial: 5.5%, 2010: 12.6%, 2019: 13.4%, P <0.001). Hispanic trial representation was significantly lower compared to the US population (trial: 10.6%, 2010: 16.3%, 2019: 18.3%, P <0.001). NHW trial participation was lower compared to the US population (trial 69.2%; 2010: 72.4%; 2019: 76.5%, P <0.001), but with smaller relative differences compared to Black and Hispanic representation. Asian participation was higher than US census representation. Conclusion: Among guideline-driving cholesterol RCTs, Black and Hispanic participants are significantly underrepresented compared to the general U.S. population. Few studies disaggregate major racial/ethnic subgroups. These findings represent a source of systemic bias that may limit the generalizability of trials and guidelines and potentiate health inequities.

Do Federal Regulations Affect Gender, Racial, and Ethnic Disparities in Chronic Rhinosinusitis Research?

2021 ◽  
pp. 019459982110210
Author(s):  
Daniel B. Spielman ◽  
Rodney J. Schlosser ◽  
Andi Liebowitz ◽  
Rahul Sharma ◽  
Jonathan Overdevest ◽  
...  
Keyword(s):  
Clinical Trials ◽  
American Indian ◽  
Chronic Rhinosinusitis ◽  
Census Data ◽  
Ethnic Disparities ◽  
The Us ◽  
And Gender ◽  
Us Census ◽  
Federal Guidelines ◽  
Racial Ethnic

Objective The Food and Drug Administration and the National Institutes of Health (NIH) have asserted that diverse demographic representation in clinical trials is essential. In light of these federal guidelines, the objective of this study is to assess the racial, ethnic, and gender demographics of patients enrolled in clinical trials registered with the NIH that evaluate chronic rhinosinusitis with nasal polyposis (CRSwNP) relative to the demographics of the US population. Study Design Cross-sectional study. Setting Not applicable. Methods ClinicalTrials.gov was queried to identify all prospective clinical trials for CRSwNP. Individual study and pooled data were compared with national US census data. Results Eighteen studies were included comprising 4125 patients and evaluating dupilumab, mepolizumab, omalizumab, fluticasone/OptiNose, MediHoney, mometasone, and SINUVA. Women constituted 42.7% of clinical trial participants. Of the 4125 participants, 69.6% identified as White, 6.6% as Black, 20.8% as Asian, 0.1% as Pacific Islander, 0.4% as American Indian, 8.0% as Hispanic, and 2.4% as other. The racial, ethnic, and gender composition of the pooled study population differs significantly from national US census data, with underrepresentation of Black, Hispanic, Pacific Island, and American Indian individuals, as well as females ( P < .05). Conclusion The racial, ethnic, and gender demographics of patients enrolled in CRSwNP clinical trials registered with the NIH differ significantly from the demographics of the US population, despite federal guidelines advising demographically representative participation. Proactive efforts to enroll participants that better represent anticipated treatment populations should be emphasized by researchers, institutions, and editorial boards.

scholarly journals How differential privacy will affect our understanding of population growth in the United States

2020 ◽  
Author(s):  
Alexis R Santos-Lozada ◽  
Danilo T Perez-Rivera ◽  
Aarti C. Bhat
Keyword(s):  
Population Growth ◽  
Census Data ◽  
Differential Privacy ◽  
The United States ◽  
The Us ◽  
Potential Impact ◽  
Us Census ◽  
Population Counts ◽  
Metropolitan Counties ◽  
Racial Ethnic

The implementation of a proposed differential privacy algorithm to 2020 US Census data releases, and other census products has brought about discussions about the consistency and reliability of the data produced under the proposed disclosure avoidance system. We test the potential impact of this change in disclosure avoidance systems to the tracking of population growth and distribution using county-level population counts. We ask how population counts produced under the differential privacy algorithm might lead to different conclusions regarding population growth for the total population and three major racial/ethnic groups in comparison to counts produced using the traditional methods. Our results suggest that the implementation of differential privacy, as proposed, will impact our understanding of population changes in the US. We find potential for overstating and understating growth and decline, with these effects being more pronounced for non-Hispanic blacks and Hispanics, as well as for non-metropolitan counties. These findings draw attention to the potential local consequences of the implementation of differential privacy for tracking demographic changes of the US population, which is bound to have implications for our understanding of the transformations the nation is going through.

scholarly journals Racial, Ethnic, and Sex Disparities in Nail Psoriasis Clinical Trials: A Systematic Review

2022 ◽  
pp. 1-8
Author(s):  
Jose W. Ricardo ◽  
Yuqing Qiu ◽  
Shari R. Lipner
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Nail Psoriasis ◽  
Treatment Type ◽  
The Us ◽  
Race Ethnicity ◽  
Pharmacologic Treatments ◽  
Us Census ◽  
Racial Ethnic

<b><i>Introduction:</i></b> Nail psoriasis (NP) disproportionally affects quality of life in females versus males. Demographics of NP research cohorts are not well characterized. In this systematic review, we characterize the representation of racial/ethnic groups and women in NP randomized clinical trials (RCTs). <b><i>Methods:</i></b> A systematic search of MEDLINE was performed; RCTs of NP pharmacologic treatments or cutaneous psoriasis/psoriatic arthritis with the number of NP patients described were included. <b><i>Results:</i></b> Overall, 45 RCTs were analyzed, with 91.1% reporting sex, and 67.9% of participants were men. 7/41 (17%) studies reporting sex included ≥45% female participants. Of 45 RCTs, 35.6% reported race and/or ethnicity. Of the 22 studies with ≥1 US-based site, 13 (59%) reported race/ethnicity; 3 out of 23 (13%) studies with &#x3c;1 US-based site reported these data. Enrollment of nonwhite participants was significantly lower than representation within the US census (13.4% vs. 39.9%; <i>p</i> &#x3c; 0.001). Treatment type, route of administration, location with ≥1 US-based site, funding, and journal type were significantly associated with race/ethnicity reporting (<i>p</i> &#x3c; 0.05 all comparisons). <b><i>Discussion/Conclusion:</i></b> Reporting of racial/ethnic demographics is lacking in NP RCTs. Women and racial/ethnic minorities remain underrepresented in NP research. There is a need for increased reporting and diversification of NP clinical trial participants.

Choice and Conflict about Census Data Adjusting the American Census Count

1991 ◽  
Vol 11 (4) ◽  
pp. 357-398 ◽  
Author(s):  
Michael L. Cohen
Keyword(s):  
Census Data ◽  
Political Representation ◽  
The United States ◽  
Political Conflict ◽  
Census Bureau ◽  
Census Count ◽  
Social Fact ◽  
The Us ◽  
Census Adjustment ◽  
Us Census

ABSTRACTThe census is a social fact, the outcome of a process that involves the interaction of public laws and institutions and citizens' responses to an official inquiry. However, it is not a ‘hard’ fact. Reasons for inevitable defects in the census count are listed in the first section; the second section reports efforts by the US Census Bureau to identify sources of error in census coverage, and make estimates of the size of the errors. The use of census data for policy purposes, such as political representation and allocating funds, makes these defects controversial. Errors may be removed by making adjustments to the initial census count. However, because adjustment reallocates resources between groups, it has become the subject of political conflict. The paper describes the conflict between statistical practices, laws and public policy about census adjustment in the United States, and concludes by considering the extent to which causes in America are likely to be found in other countries.

scholarly journals The prevalence of MS in the United States

Neurology ◽  
2019 ◽  
Vol 92 (10) ◽  
pp. e1029-e1040 ◽  
Author(s):  
Mitchell T. Wallin ◽  
William J. Culpepper ◽  
Jonathan D. Campbell ◽  
Lorene M. Nelson ◽  
Annette Langer-Gould ◽  
...  
Keyword(s):  
United States ◽  
Census Data ◽  
Adult Population ◽  
The United States ◽  
Health Claims ◽  
The North ◽  
Time Period ◽  
The Us ◽  
Group A ◽  
Us Census

ObjectiveTo generate a national multiple sclerosis (MS) prevalence estimate for the United States by applying a validated algorithm to multiple administrative health claims (AHC) datasets.MethodsA validated algorithm was applied to private, military, and public AHC datasets to identify adult cases of MS between 2008 and 2010. In each dataset, we determined the 3-year cumulative prevalence overall and stratified by age, sex, and census region. We applied insurance-specific and stratum-specific estimates to the 2010 US Census data and pooled the findings to calculate the 2010 prevalence of MS in the United States cumulated over 3 years. We also estimated the 2010 prevalence cumulated over 10 years using 2 models and extrapolated our estimate to 2017.ResultsThe estimated 2010 prevalence of MS in the US adult population cumulated over 10 years was 309.2 per 100,000 (95% confidence interval [CI] 308.1–310.1), representing 727,344 cases. During the same time period, the MS prevalence was 450.1 per 100,000 (95% CI 448.1–451.6) for women and 159.7 (95% CI 158.7–160.6) for men (female:male ratio 2.8). The estimated 2010 prevalence of MS was highest in the 55- to 64-year age group. A US north-south decreasing prevalence gradient was identified. The estimated MS prevalence is also presented for 2017.ConclusionThe estimated US national MS prevalence for 2010 is the highest reported to date and provides evidence that the north-south gradient persists. Our rigorous algorithm-based approach to estimating prevalence is efficient and has the potential to be used for other chronic neurologic conditions.

Representation of minorities in randomized lung cancer trials in the United States.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16517-e16517
Author(s):  
Mounika Mandadi ◽  
Goetz H. Kloecker
Keyword(s):  
Lung Cancer ◽  
African Americans ◽  
Cancer Mortality ◽  
Randomized Trials ◽  
Randomized Clinical Trials ◽  
Census Data ◽  
Lung Cancer Mortality ◽  
The United States ◽  
Average Percentage ◽  
The Us

e16517 Background: The SEER data base shows a higher rate of lung cancer mortality for African Americans and a lower lung cancer mortality rate of Hispanics compared to Caucasians in the US. It is not clear if this is due to socioeconomic or biological factors. This study reviews the representation of Caucasians, African Americans (AA), Hispanics, and Asians in recent randomized trials published in the US. Methods: A systematic review was done of randomized trials in lung cancer published in the NEJM, JAMA, JCO. The percentage of patients of each race in the individual trials was listed. An average percentage with mean standard error for Caucasian, African-American, Hispanic and Asian race was obtained. The percentage for each group is compared to the racial distribution in the US Census data. Results: 30 randomized clinical trials were analyzed for racial distribution. A total of 227,411 patients were enrolled in the trials. Conclusions: African Americans and Hispanics have been significantly underrepresented in randomized trials published in the US. This affects the external validity of the trial results when generalizing the results to these minorities. Strategies to ensure accrual of people of all races are required to ameliorate the disparities clinical trial enrollment. [Table: see text]

Changes in clinical trial participation among adolescent and young adult (AYA) cancer patients from 2006 to 2013 in the United States.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18037-e18037 ◽  
Author(s):  
Theresa Keegan ◽  
Dolly Penn ◽  
Qian Li ◽  
Brad Pollock ◽  
Marcio H. Malogolowkin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Hodgkin Lymphoma ◽  
The United States ◽  
Trial Participation ◽  
Clinical Trial Participation ◽  
Racial Ethnic ◽  
Over Time

e18037 Background: Stagnant outcomes for AYAs (15 to 39 years) with cancer are partly attributed to poor enrollment onto clinical trials. Initiatives have focused on increasing accrual, but changes at the population-level are unknown. We examined patterns of clinical trial participation over time in AYA cancer patients. Methods: We utilized medical record data from AYAs in two National Cancer Institute Patterns of Care Studies identified through the Surveillance, Epidemiology and End Results (SEER) Program. Among 1,358 AYAs diagnosed with non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), acute lymphoblastic leukemia (ALL), germ cell cancer, and sarcoma in 2006 and 3,560 AYAs diagnosed with NHL, HL, ALL, sarcoma, and breast cancer in 2012/2013, we used unconditional logistic regression to evaluate patient and provider characteristics associated with enrollment by year of diagnosis. Analyses were weighted to reflect the SEER populations and associations are summarized as adjusted odds ratios (OR) with 95% confidence intervals (CI). Results: From 2006 to 2012/2013, clinical trial participation increased from 14.8% to 17.9% among AYAs diagnosed with NHL, HL, ALL and sarcoma (p < 0.0001), primarily due to increased participation among ALL patients (2006: 37.4%; 2012/2013: 42.3%). In 2012/2013, participation varied by type of cancer, with the highest among those with ALL and sarcoma (31.2%), followed by HL (9.4%), NHL (6.9%) and breast cancer (4.3%). In both study years, multivariate analyses demonstrated that younger patients and those treated by pediatric oncologists (OR = 3.5; CI: 2.6-4.7) were more likely to enroll onto clinical trials. Uninsured AYAs were less likely to enroll in 2006 but no association was observed in 2012/2013. Hispanic (OR = 0.5; CI: 0.4-0.6), Black (OR = 0.6; CI: 0.5-0.9) and Asian (OR = 0.4; CI: 0.3-0.6) AYAs were less likely to enroll in 2012/2013 but not 2006. Conclusions: Our study identified increasing overall clinical trial participation over time. Disparities in likelihood of participating for racial/ethnic minority groups increased suggesting the need to improve access to clinical trials for all racial/ethnic groups to improve care and outcomes.

scholarly journals 690 Are participants in obstetrical randomized clinical trials representative of the United States pregnant population?

2021 ◽  
Vol 224 (2) ◽  
pp. S433
Author(s):  
Cynthia Coots ◽  
Stephen Wagner ◽  
Matthew J. Bicocca ◽  
Megha Gupta ◽  
Hector Mendez Figueroa ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
The United States

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.

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