Racial and Ethnic Disparities in Clinical Trials and Peripheral Arterial Disease

Elsevier

Available online 28 December 2022

Seminars in Vascular SurgeryAuthor links open overlay panelAbstract

As peripheral arterial disease (PAD) continues to plague many citizens in our population, the search continues for medical advances to improve the treatment algorithms for this debilitating disease. Prior research studies have more than adequately documented the disparity that exists in the outcomes of patients with PAD based on race and ethnicity. One of the paths to clinical improvement and removal of the disparate outcomes is through application of the studied variables in a well-constructed clinical trial. Unfortunately, the groups that are known for worse outcomes are also those with limited enrollment into clinical trials, which exacerbates the problem. The following manuscript will evaluate the issue of underrepresentation of racial and ethnic minority populations in clinical trials, address factors contributing to the problem, and provide possible pathways to a viable solution.

Introduction

For medicine to continue to advance, the role of clinical trials is of great importance. Since the introduction of the United States (US) Food, Drug, and Cosmetic Act in 1938, reliance on evidence for the safety and effectiveness of advancements in healthcare has been central. Clinical trials are the peak of experimental models in medical research and serve to evaluate new protocols and treatment regimens to assure the best possible outcomes for patients. However, for clinical trials to be the most effective, the participants must reflect the target population of the study, including the racial, ethnic, and gender distribution within the population. Without adequate amount of diversity in the clinical trials, implementation of newly discovered treatment regimens become isolated rather than universally applicable.1 This article reviews historical and current issues of racial and ethnic diversity in clinical trials and peripheral arterial disease (PAD).

Section snippetsHistoric Lack of Diversity in Clinical Trials

In 1993, based on the accumulating concern about the underrepresentation of women and racial and ethnic minority groups in nationally funded research, the National Institute of Health (NIH) Revitalization Act was signed into law, which required for the first time the inclusion of underrepresented populations in all NIH-funded research at an appropriate level.2 Despite being aware of the need for diversity, participation of racial and ethnic minority groups in clinical trials is lagging. Chen

Need for Diversity in Clinical Trials

Health equity has been defined as the principle of reducing and eliminating disparities in health and health determinants by striving for the highest standard of health for all people, especially for the needs of those at the greatest risk for poor health based on social conditions.7 Health equity applies not only to Black and Hispanic individuals, but to all minority communities and low socioeconomic status communities.8 If the consensus amongst providers treating PAD is that health equity is

Barriers and Attitude Towards Medical Research

The tragic history of the relationship of racial and ethnic minority patients and the medical field has hindered some patient's potential involvement in clinical trials. Examples include the disproportionate sterilization of Hispanic men and women in California in the 20th century. The state's eugenics laws allowed for sterilization of people who were considered feebleminded or who had mental conditions that could be transmitted to descendants. Likely due to structural racism and biases,

Issues Using Race and Ethnicity in Research

There are many perspectives and reports regarding the issues with using race and ethnicity in research. Race and ethnicity are complex variables as even the definitions are based on different aspects including skin color, national origin, and ancestry that are formed from sociopolitical constructs rather than scientific categorization. Also, the groups can be very broad and non-specific, such as the aggregation of many racial and ethnic subgroups into “Asian-American”. Complicating racial and

Peripheral Arterial Disease Clinical Trials

Most clinical trials for PAD have not fared better than trials in other areas and are poorly representative of the diversity present in the US and throughout the world. Just a few examples are mentioned here. The bypass versus angioplasty for severe ischaemia of the leg (BASIL) trial didn't collect race and ethnicity data as part of the study.28 The authors argued that this data is difficult to define, is not as useful across international borders, and is less important in places like the

Fixing the Problems

Undoubtedly, participant barriers limiting enrollment into clinical trials is an issue, however, other stakeholders in the trial process must accept some level of culpability, including investigators, sponsors, and even clinical coordinators (Table 1). The first step in the process of improvement is the acknowledgement that health equity and diversity are necessary in the research of PAD. Without this acknowledgement, changes are unlikely to occur. Next, the basic design of trials needs to be

References

1. Carson P, Ziesche S, Johnson G, Cohn JN. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. J Card Fail. Sep 1999;5(3):178-87. doi:10.1016/s1071-9164(99)90001-5

2. National Institutes of Health Revitalization Act of 1993: Act to Amend the Public Health Service Act to Revise and Extend the Progras of the National Institutes of Health, and for Other Purposes. Public Law 103-43. (June 20,

Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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