Reporting of Participant Race, Sex, and Socioeconomic Status in Randomized Clinical Trials in General Medical Journals, 2015 vs 2019

Alegria, Mikhaila; Sud, Shawn; Steinberg, Benjamin E.; Gai, Nan; Siddiqui, Asad

doi:10.1001/jamanetworkopen.2021.11516

Cited by 55 publications

(30 citation statements)

References 5 publications

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“…Additionally, if CMS first requires large-scale randomized clinical trial evidence to endorse the clinical benefits of telehealth CR as an option for standard of care, acquiring such data in a representative patient cohort of diverse social and economic backgrounds could prove extremely challenging and biased without universal fixed-terrestrial broadband internet access already in-place. Equitable representation of patients exhibiting characteristics predictive of low socioeconomic status in randomized clinical trials is rare and an ongoing concern for the development of medical treatments and improving access to preventive healthcare [31] , [32] , [33] .…”

Section: Discussionmentioning

confidence: 99%

National, regional, and urban-rural patterns in fixed-terrestrial broadband internet access and cardiac rehabilitation utilization in the United States

Iterson

Laffin

Cho

2023

American Journal of Preventive Cardiology

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Section: Discussionmentioning

confidence: 99%

National, regional, and urban-rural patterns in fixed-terrestrial broadband internet access and cardiac rehabilitation utilization in the United States

Iterson

Laffin

Cho

2023

American Journal of Preventive Cardiology

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“… 17 , 18 Do Black patients, who are underrepresented in clinical trials, derive benefit from agents differently from their White counterparts, requiring more intensive or additional novel treatments? 19 Can these differences be explained by a lack of racial diversity among the health care workforce? 20 To understand how to deliver better care, research is needed to garner a better understanding of the factors that contribute to racial disparities across SES levels among Black and White Americans.…”

Section: Discussionmentioning

confidence: 99%

Interaction Between Race and Income on Cardiac Outcomes After Percutaneous Coronary Intervention

Kumar

Ogunnowo

Khot

et al. 2022

JAHA

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Background Compared with White Americans, Black Americans have a greater prevalence of cardiac events following percutaneous coronary intervention. We evaluated the association between race and neighborhood income on post–percutaneous coronary intervention cardiac events and assessed whether income modifies the effect of race on this relationship. Methods and Results Consecutive patients (n=23 822) treated with percutaneous coronary intervention from January 1, 2000, to December 31, 2016, were included. All‐cause mortality and major adverse cardiac event were assessed at 3 years. Extended 10‐year follow‐up was performed for those residing locally (n=1285). Neighborhood income was derived using median adjusted annual gross household income reported within the patient's zip code. We compared differences in treatment and outcomes, adjusting for race, income, and their interaction. In total, 3173 (13.3%) patients self‐identified as Black Americans, and 20 649 (86.7%) self‐identified as White Americans. Black Americans had a worse baseline cardiac risk profile and lower neighborhood income compared with White Americans. Although risk profile improved with increasing income in White Americans, no difference was observed across incomes among Black Americans. Despite similar long‐term outpatient cardiology follow‐up and medication prescription, risk profiles among Black Americans remained worse. At 3 years, unadjusted all‐cause mortality (18.0% versus 15.2%; P <0.001) and major adverse cardiac event (37.3% versus 34.6%; P <0.001) were greater among Black Americans and with lower income (both P <0.001); race, income, and their interaction were not significant predictors in multivariable models. At 10‐year follow‐up, increasing income was associated with improved outcomes only in White Americans but not Black Americans. In multivariable models for major adverse cardiac event, income (hazard ratio [HR], 0.97 [95% CI, 0.96–0.98]; P =0.005), Black race (HR, 1.77 [95% CI, 1.58–1.96]; P =0.006), and their interaction (HR, 0.98 [95% CI, 0.97–0.99]; P =0.003) were significant predictors. Similar findings were observed for cardiac death. Conclusions Early 3‐year post–percutaneous coronary intervention outcomes were driven by worse risk factor profiles in both Black Americans and those with lower neighborhood income. However, late 10‐year outcomes showed an independent effect of race and income, with improving outcomes with greater income limited to White Americans. These findings illustrate the importance of developing novel care strategies that address both risk factor modification and social determinants of health to mitigate disparities in cardiac outcomes.

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“…The extent of race-and sex-based disparities in clinical research has been documented extensively across the field of medicine. [7][8][9][10][11][12][13][14][15][16]35 Although the enrollment of women has improved over time, many racial and ethnic populations remain under-represented. 15 Recent reports indicate that the substantial imbalance in participant enrollment by race and ethnicity in clinical trials persists.…”

Section: Lack Of Diversity In Clinical Trials a Long-standing History...mentioning

confidence: 99%

“…11,15,16 In a study of clinical trials published in JAMA, The Lancet, and the New England Journal of Medicine between 2015 and 2019 (688 studies), approximately one-half reported race; of those studies, the highest proportion of participants were White (ranging from 84% in 2015 to 77% in 2019), with substantially less participation among other racial and ethnic groups. 35 Among 20,692 US-based clinical trials from 2000 to 2020 with reported results, only 43% reported race and ethnicity data, and ~80% of participants were White. 10 Compared with US Census data, White patients are overrepresented in clinical trials, especially in light of the changing demographics of the United States, with the proportion of people identifying as White (as their only race) decreasing from 75% in 2000 36 to 61% in 2020.…”

Section: Lack Of Diversity In Clinical Trials a Long-standing History...mentioning

confidence: 99%

A Review of the Evolving Landscape of Inclusive Research and Improved Clinical Trial Access

Mohan¹,

Freedman²

2023

Clin Pharma and Therapeutics

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Current clinical research does not reflect the diversity of patient populations, despite continued recommendations to increase enrollment of under‐represented racial and ethnic groups. The ramifications of this lack of trial diversity are important because of potential differences between races and ethnicities in response to therapies, which have been observed for drugs across indications. Nonrepresentative research populations limit the generalizability of study results, which may lead to questions about safety and efficacy in certain subgroups of patients and hinder regulators, healthcare providers, and patients in their ability to adequately consider the benefits and risks of a therapeutic treatment across all populations. Renewed efforts to address healthcare disparities and increase diversity in clinical trials have demonstrated that inclusive trials are achievable and can provide scientifically rigorous results, and, thus, should stimulate greater action across all stakeholders. Ensuring that studies throughout the clinical development process include representative populations is a scientific imperative to advance health equity, racial justice, and trust in the safety and efficacy of medical therapies. This article reviews the long‐standing lack of diversity and barriers to enrollment of diverse and representative populations in clinical trials, outlines the current evolving trial landscape and the efforts of stakeholders, and provides examples from scientifically rigorous inclusive trials. The goal is to share learnings in a wider context of opportunities to enhance diversity, equity, and inclusion in clinical development while ensuring the safety and efficacy of medical therapies in all populations of patients, and in doing so, provide wider patient access to therapeutic treatments.

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Reporting of Participant Race, Sex, and Socioeconomic Status in Randomized Clinical Trials in General Medical Journals, 2015 vs 2019

Abstract: This cross-sectional study evaluates changes in reporting practices for race, sex, and socioeconomic status in randomized clinical trials in 2015 vs 2019.

Cited by 55 publications

References 5 publications

National, regional, and urban-rural patterns in fixed-terrestrial broadband internet access and cardiac rehabilitation utilization in the United States

National, regional, and urban-rural patterns in fixed-terrestrial broadband internet access and cardiac rehabilitation utilization in the United States

Interaction Between Race and Income on Cardiac Outcomes After Percutaneous Coronary Intervention

A Review of the Evolving Landscape of Inclusive Research and Improved Clinical Trial Access

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