# Beyond Diversity: Addressing Equity and Enrollment in a Clinical Trial Network Model

> **NIH NIH U01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2021 · $48,798

## Abstract

Project Summary/Abstract:
 In the 40 years since the publication the Belmont Report in 1979 Black, Indigenous, and other people of
color (BIPOC) have gone from bearing an undue burden of involuntary participation in clinical research to
being excluded from receiving its benefits. Clinical trial populations in the United States are not racially or
ethically representative of the US population and these disparities have existed and been studied for decades.
Prevailing research primarily attributes such disparities to patient distrust, health literacy, and logistical barriers,
all of which overemphasize the role of the individual and do not recognize the role of institutional barriers and
structural racism. An opportunity exists to reframe the medical imperative of racial and ethnic parity in clinical
trials from one that legitimizes pseudoscientific notions of biological race to one of justice informed by
contemporary racial scholarship.
 This project will present a case study of the Cardiothoracic Surgical Trial Network, a well-established
and successful clinical trials network created by the NHLBI to advance the surgical treatment of cardiovascular
disease. Despite naming the enrollment of diverse populations as key element of its mission, the CTSN has
not reached its stated goal and three of the five most recent studies in have enrolled patient populations that
were more than 90% white and non-Hispanic. The primary aim of this study is to assess whether the network
model compounds systemic barriers to the recruitment of BIPOC and identify possible interventions using the
interdisciplinary framework of Critical Race Theory.
 Critical Race Theory emphasizes the social construction of race, the structural nature of racism, the
positionality of the researcher, the lived experience of marginalized individuals, and the application of research.
A quantitative analysis of CTSN trial demographic data and site demographic data will be performed to
establish whether there are racial and ethnic disparities related to geographic and site population constraints
(structural/institutional discrimination). Based on the quantitative analysis, 3-4 network sites will be chosen for
case studies and qualitative interviews will be conducted with site staff. Interview data will be compiled and
reviewed using descriptive statistics (positionality). An intervention plan for the network and a site evaluation
tool will be developed based on the results of the project (praxis) and can serve as a model for other NIH
networks

## Key facts

- **NIH application ID:** 10415758
- **Project number:** 3U01HL088942-14S1
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Anne Christine Gelijns
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $48,798
- **Award type:** 3
- **Project period:** 2021-09-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10415758

## Citation

> US National Institutes of Health, RePORTER application 10415758, Beyond Diversity: Addressing Equity and Enrollment in a Clinical Trial Network Model (3U01HL088942-14S1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10415758. Licensed CC0.

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