Clinical Research Diversity Controversy: Fact or Myth?
Recently news headlines are flooded with controversy over diversity and inclusion, with an emphasis on the college admissions process. Most recently, Alabama passed sweeping legislation banning diversity, equity and inclusion practices at public universities, local boards of education and government agencies.
Within the clinical space, diversity and inclusion remain pivotal topics, but they need not be sources of controversy. To provide clarity amidst common misconceptions, we present this concise assessment of fact versus myth regarding Diversity and Inclusion in Clinical research.
Fact or Myth?
Diversity initiatives in Clinical Research are disproportionately targeting underserved minorities.
MYTH! While controversial college admission practices are argued to disproportionately advantage minorities, diversity in clinical research advocates for including a study population that is representative of the group that is being studied. Historically, both minorities and women are underrepresented relative to their global population. For instance, while women study participants were 42% of study population, they constituted 54% of the global population for the diseases studied.1 Diversity in clinical trials is imperative for comprehending how new interventions impact various experiences and conditions.
Diversity, Equity and Inclusion are Synonymous.
MYTH! While often used interchangeably, each term holds distinct significance. The National Institute on Minority Health and Health Disparities (NIMHD) outlines it as the characteristics that can affect a patient’s health and response to treatment.2 In a nutshell, diversity refers to the traits and characteristics of people, such as race, ethnicity, age, and sex.
On the other hand, equity refers to equal access to the same opportunities.3 Studies should be designed to encourage participation from diverse populations of patients. Are the sites accessible? Are forms easily understood? What hours are you requiring patients to be available.
Lastly, inclusion. While diversity refers to specific characteristics, inclusion refers to their behaviors. The World Health Organization defines inclusion as determined by the conditions in which people are born, grow, live, work, play and age, which have a significant impact on a patient’s willingness and ability to participate.4 If diversity and equity are adequately considered, inclusion will be addressed by default.
Patients of Middle Eastern and North African (MENA) descent are classified as white.
FACT! While the National Institutes of Health (NIH) and the Office of Management and Budget (OMB) have taken steps to promote diversity and inclusion, their minimum reporting categories—American Indian or Alaskan Native, Asian or Pacific Islander, Black, Hispanic, and White—fail to encompass the rich diversity of all populations.5
The inclusion of individuals of Middle Eastern and North African (MENA) descent within the White reporting group is just one illustration of these shortcomings. Such oversights perpetuate inaccuracies in representation and hinder our understanding of how different demographic groups respond to medical interventions and treatments.
This practice not only affects patients' comfort and willingness to consent but also hampers the ability of MENA researchers to apply for minority grants. Greater granularity in reporting is warranted to address disparities and nuances in race and ethnicity until more formal guidance is provided.
As we strive for more inclusive and equitable clinical research practices, it's imperative to recognize and address these gaps in classification. By advocating for more comprehensive reporting standards that reflect the full diversity of the populations being studied, we can ensure that research outcomes are more accurate, relevant, and beneficial for all individuals.
References:
Feldman S, Ammar W, Lo K, Trepman E, van Zuylen M, Etzioni O. Quantifying Sex Bias in Clinical Studies at Scale With Automated Data Extraction. JAMA Netw Open. 2019;2(7):e196700. Published 2019 Jul 3. doi:10.1001/jamanetworkopen.2019.6700
National Institute on Minority Health and Health Disparities. Diversity and Inclusion in Clinical Trials. National Institute on Minority Health and Health Disparities website. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html. Published 2024 Jan 12. Accessed 2024 Mar 19.
Applied Clinical Trials Online. Diversity in Clinical Trials: Strategies and Challenges. https://www.appliedclinicaltrialsonline.com/view/diversity-in-clinical-trials-strategies-and-challenges. Published 2023 Mar 7. Accessed 2024 Mar 19.
World Health Organization. Health equity. World Health Organization website. https://www.who.int/health-topics/health-equity#tab=tab_1. Published 2010. Accessed 2024 Mar 19.
Recommendations from the Interagency Committee for the Review of the Racial and Ethnic Standards to the Office of Management and Budget Concerning Changes to the Standards for the Classification of Federal Data on Race and Ethnicity. Office of Management and Budget; 1997:36873-36946. https://obamawhitehouse.archives.gov/omb/fedreg_directive_15?msclkid=1fa9d163b68f11ec8a12802b5e1ae944