Where Are All The Arabs? And How A U.S. Census Change Could Improve Clinical Trial Diversity

This article is part one of a three-part series on Arab participation in clinical research. Part two and part three are now available.

With approximately 500 million Arabs residing in the 22 Arab countries and an estimated 4. million (depending on who’s counting) residing in the United States^1,2,3, this diverse group of people linked by their ethnicity, language, culture, and other factors accounts for a not-so-tiny part of the human race. And while they represent just 1.5% of the U.S. population — and African Americans and Hispanics represent roughly 14% and 19%, respectively — there are several justifications for advocating for their distinct inclusion in clinical trials.

To be clear, Arabs are included in clinical research. However, they are currently categorized as whites. And as such, there’s no real way to tell how many are participating in clinical research. Yes, Arabs are inappropriately lumped with people whose lived experience can be distinctly different from theirs. Aside from the glaring socioeconomic issues with doing so, grouping individuals from diverse genetic backgrounds under a single racial category can be problematic in clinical research. This practice overlooks important genetic differences and limits the applicability of research findings. Genetic differences within and between populations can have implications for disease susceptibility, disease progression, drug metabolism, and treatment response. Failing to account for this diversity can lead to biases in clinical research findings and limit the generalizability of results to specific populations.

Why Arabs Should Be Identified As Such In Clinical Research

On its face, the importance of distinguishing Arabs as a separate category from whites recognizes their unique ethnic and cultural identity. Arabs have distinct cultural practices, languages (such as Arabic), traditions, and historical experiences that set them apart from whites and others. Treating Arabs as a separate category acknowledges and respects their specific heritage, challenges, and contributions to society.

But Arabs are also a diverse group of people with a range of genetic variations that can impact drug metabolism and disease susceptibility. For example, Arabs have been shown to have a high prevalence of genetic variations that affect drug metabolism, such as CYP2C19 polymorphisms. Depending on CYP2C19 polymorphism, some individuals may be poor metabolizers, while others are extensive metabolizers, affecting how certain drugs are processed in the body. Other cytochrome P450 enzymes, such as CYP3A4 and CYP3A5, also exhibit genetic polymorphisms among Arab populations. These enzymes are involved in the metabolism of many drugs, and their variability can impact drug levels and efficacy. The sickle cell trait, caused by the HbS gene mutation, is also more prevalent in some Arab populations. This genetic variation can impact drug pharmacokinetics and pharmacodynamics, influencing clinical trial outcomes and drug response. What’s more, Arabs are also known to have higher rates of certain diseases, such as diabetes and heart disease, compared to other populations.

Arabs also have unique cultural and environmental factors that could impact their health outcomes. For example, dietary habits, lifestyle factors, and exposure to certain toxins or pollutants could affect their response to drugs or susceptibility to disease. Clinical trials involving Arabs and Arab Americans can shed light on population-specific factors that influence health outcomes, such as genetic predispositions or specific disease patterns. This knowledge can guide create more personalized decision-making and improve healthcare strategies targeted to these communities. This could also have a significant impact on generalizability and external validity of study findings of clinical trials.

Change Could Be On The Horizon

As it stands, the U.S. Census counts Arabs as part of the "white" racial category. However, a recent federal register proposal aims to establish a separate category for individuals from the Middle East and North Africa (MENA) in time for the upcoming 2030 U.S. census. MENA is often used interchangeably with Arab, but distinctions can be made depending on the defining party.  Still, this proposal is timely and is receiving encouragement and welcome from various diversity and advocacy groups like grassroots coalitions, the Arab American Institute Foundation (AAI), and the American-Arab Anti-Discrimination Committee (ADC).

When it comes to clinical research, adding MENA as a race will ensure that the safety and effectiveness of medical interventions are adequately assessed as they occur specifically in Arab populations. Pharmaceutical companies conducting clinical trials can better identify and recruit appropriate individuals, fulfill FDA diversity mandates, help generate demographic and other data relating to the safety and effectiveness of medical interventions for individuals from MENA communities, and support regulatory decision-making.

References:

1. Population, Total. World Bank. (2023). Retrieved from https://data.worldbank.org/indicator/SP.POP.TOTL
2. United States Census. (2023). Retrieved from https://www.census.gov/
3. Current World Population. Worldometer. (2023). Retrieved from  https://www.worldometers.info/world-population/ based on estimated from the Population Division of The United Nations: https://population.un.org/wpp/

About The Author:

Hadi Danawi, Ph.D., is a professor in global public health and epidemiology. He is actively engaged in industrywide projects relating to remote consulting, higher education (master and doctoral programs in public health/healthcare administration), and clinical trial design and management. Danawi created the Arab Board for Clinical Research to promote diversity and inclusion of Arabs and Arab Americans in clinical research, the use of DCTs, and education and staffing of Arabs and Arab Americans in clinical research.

Danawi has expertise with pharmaco-epidemiology and drug safety/pharmacovigilance with Big Pharma, including outcomes research and RWE. He is passionate about creating positive social change in underserved communities in Africa and the Middle East and so established a not-for-profit organization with chapters in Lebanon and Ghana to provide technical assistance for project implementation, curriculum development, and training of local associates for self-reliance in disease prevention, health services, and family and community health initiatives.