Despite The FDA’s Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs

Green, Angela K; Trivedi, Niti U.; Hsu, Jennifer J; Yu, Nancy L.; Chimonas, Susan

doi:10.1377/hlthaff.2021.01432

Cited by 26 publications

(25 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…6 However, almost 30 years later and despite continued recommendations and guidance to increase enrollment of under-represented racial and ethnic groups, current clinical research does not reflect the diversity of patient populations, with White patients often over-represented among clinical trial participants. [7][8][9][10][11][12][13][14][15][16] This lack of progress is even more concerning because under-represented racial and ethnic groups are often at a higher risk of developing or dying from numerous illnesses and diseases, such as certain types of cancer, diabetes, hypertension, and severe coronavirus disease 2019 (COVID-19). [17][18][19][20][21][22][23] The reasons for the lack of diversity in clinical trials are complex and multifactorial, including lack of trial awareness and access, along with structural racism and implicit bias that limit which patients are offered trial participation; overly restrictive eligibility criteria; financial and logistical barriers for patients; and mistrust of the healthcare system.…”

Section: A Review Of the Evolving Landscape Of Inclusive Research And...mentioning

confidence: 99%

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

Mohan¹,

Freedman²

2023

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

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.

show abstract

Section: A Review Of the Evolving Landscape Of Inclusive Research And...mentioning

confidence: 99%

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

Mohan¹,

Freedman²

2023

Clin Pharma and Therapeutics

View full text Add to dashboard Cite

show abstract

“…It is well-known that the current state of clinical trials or scientific studies does not always match the demographics of the patient population that is at risk or suffers from the disease condition being studied. Despite a bold 5-year plan by the FDA to improve diversity and transparency in clinical trials for newly approved drugs, black patients have remained inadequately represented and, of these trials, fewer than 20% met the requirement of reporting on race-specific benefits and adverse effects ( 12 ). Our research and data generation efforts for building the evidence base and context for clinical decision-making that informs medical AI and ML algorithms should be grounded in equity and inclusion.…”

Section: Strategies For Addressing Biasmentioning

confidence: 99%

Artificial Intelligence and Machine Learning Technologies in Cancer Care: Addressing Disparities, Bias, and Data Diversity

Dankwa‐Mullan

Weeraratne

2022

Cancer Discovery

View full text Add to dashboard Cite

Summary: Artificial intelligence (AI) and machine learning (ML) technologies have not only tremendous potential to augment clinical decision-making and enhance quality care and precision medicine efforts, but also the potential to worsen existing health disparities without a thoughtful, transparent, and inclusive approach that includes addressing bias in their design and implementation along the cancer discovery and care continuum. We discuss applications of AI/ML tools in cancer and provide recommendations for addressing and mitigating potential bias with AI and ML technologies while promoting cancer health equity.

show abstract

“…4,5 Although efforts to address barriers and increase diversity and participation are ongoing, clear progress remains elusive. 1,[6][7][8] Inclusive participation in clinical trials is necessary to understand potential differences in efficacy and safety across diverse populations, mitigate racial and ethnic disparities in health outcomes, and promote equity and justice. 2,9,10 Removing barriers to enrollment and participation for people historically underrepresented in clinical trials is a critical scientific and ethical imperative for the cancer community.…”

Section: Introductionmentioning

confidence: 99%

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement

Oyer

Hurley

Boehmer

et al. 2022

JCO

116

View full text Add to dashboard Cite

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

show abstract

Despite The FDA’s Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs

Cited by 26 publications

References 7 publications

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

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

Artificial Intelligence and Machine Learning Technologies in Cancer Care: Addressing Disparities, Bias, and Data Diversity

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement

Contact Info

Product

Resources

About