Clinical Trial Eligibility Criteria: A Structural Barrier to Diversity in Clinical Trial Enrollment

Snyder, Richard A.

doi:10.1200/jco.22.00537

Cited by 7 publications

(2 citation statements)

References 11 publications

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“…However, goals toward equitable representation continue to be unmet (4,5,6). Extrinsic factors such as exclusionary eligibility criteria and insu cient outreach contribute to this disparity (7).…”

Section: Introductionmentioning

confidence: 99%

Bridging Research, Accurate Information, and Dialogue (BRAID) to Improve Trust in Clinical Research Trials

Yone,

Jacobs,

McNeilly

et al. 2024

Preprint

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Background Lack of trust in scientific research and in healthcare systems is a well-documented barrier to minoritized participation in clinical trials. Objective To apply the Bridging Research, Accurate Information and Dialogue (BRAID) model to understand barriers to participation and improve trust in science and clinical trials. Methods Community leaders from Bronx, NY community-based organizations were invited to participate in a series of BRAID Conversation Circles regarding clinical trials. Clinical and scientific guests joined to address questions. Twelve Circles were convened between June and August 2022 via Zoom. Inductive thematic analysis was used to code Circle transcripts. Pre/post surveys assessed participants' knowledge and attitudes. Results Twenty community experts participated. Ages 26–75, 71% female, 59% Non-Hispanic Black, 41% Hispanic/Latino. Five overarching themes emerged: Influence of historic and contemporary racism; Personal factors impacting participation; Motivations to participate; Methods to improve participation; BRAID as a model for restitution. Surveys demonstrated increased trust in clinical research: 85% Post vs. 38% Pre would definitely consider participating in a clinical trial; 83% Post vs. 58% Pre would definitely recommend participation to others. Conclusion The BRAID model was effective in improving trust in science and clinical research. To ensure diverse representation of marginalized populations in clinical research, interventions must be sensitive to historical injustices and address structural barriers that persist today. BRAID is an effective and reproducible model of community trust-building that has potential to provide restitution by validating experiences, emphasizing progress, and empowering trusted messengers to spread accurate health information within larger social networks.

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Section: Introductionmentioning

confidence: 99%

Bridging Research, Accurate Information, and Dialogue (BRAID) to Improve Trust in Clinical Research Trials

Yone,

Jacobs,

McNeilly

et al. 2024

Preprint

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“…Guidelines liberalized criteria for performance status, HIV, organ dysfunction, prior and current malignancies, comorbidities, prior therapies, washout periods, concomitant medication, and brain metastases ( 2-8 ). The extent to which these criteria have been implemented remains unknown, and importantly, their impact on clinical trial participation must be investigated ( 9 ).…”

mentioning

confidence: 99%

Call to action: overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria

Riner

Freudenberger

Herremans

et al. 2023

JNCI Cancer Spectrum

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Traditional clinical trial eligibility criteria restrict study populations, perpetuating enrollment disparities. We aimed to assess implementation of modernized eligibility criteria guidelines among pancreatic cancer (PC) clinical trials. Interventional PC trials in the United States since January 1, 2014 were identified via clinicaltrials.gov with December 31, 2017 as the transition for pre-/post-guidance eras. Trials were assessed for guideline compliance and compared using Fisher’s exact test. In total, 198 trials were identified; 86 (43.4%) were pre- and 112 (56.6%) post-guidance era. Improvements were seen in allowing patients with history of HIV (8.6% vs. 43.8%, p < 0.0001), prior cancer (57.0% vs. 72.3%, p = 0.034), or concurrent/stable cancer (2.1% vs. 31.1%, p < 0.0001) to participate. Most trials (>95%) were compliant with laboratory reference ranges, QTc cutoffs, and rationalizing excluding prior therapies both pre-/post-guidance eras. However, overall compliance with modernized criteria remains poor. We advocate for stakeholders to update protocols and scrutinize traditionally restrictive eligibility criteria.

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More than a participant in trials of cell and gene therapy: Hearing the voices of people living with neurodegenerative diseases

Lane

Isaacs

Mathur³

2022

International Review of Neurobiology

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Clinical Trial Eligibility Criteria: A Structural Barrier to Diversity in Clinical Trial Enrollment

Abstract: Author affiliations and support information (if applicable) appear at the end of this article.

Cited by 7 publications

References 11 publications

Bridging Research, Accurate Information, and Dialogue (BRAID) to Improve Trust in Clinical Research Trials

Bridging Research, Accurate Information, and Dialogue (BRAID) to Improve Trust in Clinical Research Trials

Call to action: overcoming enrollment disparities in cancer clinical trials with modernized eligibility criteria

More than a participant in trials of cell and gene therapy: Hearing the voices of people living with neurodegenerative diseases

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