ArticleJournal of the American Heart Association2020
Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs.
Article in Journal of the American Heart Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
84 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Patient Acceptance and Barriers to IoT Usage in Health Care: Systematic Literature Review.JMIR mHealth and uHealth · 2026Pooled it
- A Systematic Review on Participant Diversity in Clinical Trials-Have We Made Progress for the Management of Obesity and Its Metabolic Sequelae in Diet, Drug, and Surgical Trials.Journal of racial and ethnic health disparities · 2023Pooled it
- REPRESENT recommendations: improving inclusion and trust in cancer early detection research.British journal of cancer · 2023Pooled it
- Underrepresentation of women in randomized controlled trials: a systematic review and meta-analysis.Trials · 2022Pooled it
- Influenza Vaccination for Cardiovascular Prevention: Further Insights from the IAMI Trial and an Updated Meta-analysis.Current cardiology reports · 2022Pooled it
- Twenty-year trends in racial and ethnic enrollment in large diabetes randomized controlled trials.BMC medicine · 2022Pooled it
- Recruitment of Black Adults into Cardiovascular Disease Trials.Journal of the American Heart Association · 2021Pooled it
- Augmenting Engagement in Decentralized Clinical Trials for Atrial Fibrillation: Development and Implementation of a Programmatic Architecture.JMIR cardio · 2025Trial
- Mitigating the health effects of systemic racism: Evaluation of the Race-Based Stress and Trauma Empowerment intervention.Contemporary clinical trials · 2023Trial
- A/B design testing of a clinical trial recruitment website: A pilot study to enhance the enrollment of older adults.Contemporary clinical trials · 2021Trial
- Messaging Informed by Behavioral Economics and Representativeness in Clinical Research Enrollment: Four Randomized Clinical Trials.JAMA network open · 2026Article
- Enhancing representation in cardiovascular trials: Lessons from Lp(a)FRONTIERS EXPANSION in United States Black and Hispanic patients with elevated lipoprotein(a) and established atherosclerotic cardiovascular disease.American journal of preventive cardiology · 2026Article
- Enrollment of Historically Underrepresented Groups in Peripheral Arterial Disease Trials: A Systematic Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2026Review
- Barriers and Facilitators for Equitable Clinical Research Among Pragmatic Trialists: A Qualitative Study.Pragmatic and observational research · 2026Article
- Digital Strategies for Recruitment to Improve Diversity and Inclusion in Prospective Cardiovascular Clinical Research.Cardiology and therapy · 2025Article
- Sex-related differences in cardiovascular pharmacotherapy: fiction or fact? Why can't we see the evidence?European heart journal. Cardiovascular pharmacotherapy · 2025Review
- Genetics of Cholesterol and Coronary Disease Risk across Six Global Ancestries.NEJM evidence · 2025Article
- The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants-Insights from the Trials@Home RADIAL Proof-of-Concept Trial.Clinical pharmacology and therapeutics · 2025Article
- Evaluating the Science of Diversity in Clinical Trials: Design and Goals of an American Heart Association Strategic Focused Research Network.Journal of the American Heart Association · 2025Article
- CONNECT Platform to Increase Diverse Engagement and Enrollment in Cardiovascular Clinical Research: Rationale, Design, and Lessons Learned in Early Implementation.Journal of the American Heart Association · 2025Article
24 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals. In this study we investigated the 10-year trends of participation of women and minorities in pivotal trials supporting approval of new molecular entities in cardiometabolic drugs from January 2008 to December 2017. Methods and Results A list of new molecular entities was abstracted from publicly available data at Drugs@Fda. Sex and race/ethnicity data were collected from trial publications. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled. Thirty-five novel cardiovascular (n=24) and diabetes mellitus (n=11) drugs were approved by the US Food and Drug Administration during the study period. The median number of participants supporting each drug was 5930 (interquartile range, 3175-10 942). Women represented 36% (n=108 052) of trial participants (n=296 163). Women were underrepresented compared with their proportion of the disease population in trials of coronary heart disease (participation-to-prevalence ratio, 0.52), heart failure (participation-to-prevalence ratio, 0.58), and acute coronary syndrome (participation-to-prevalence ratio, 0.68). Among trial participants, 81% were white, 4% black, 12% Asian, and 11% Hispanic/Latino. There was no significant association between enrollment of women (
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.