Diversity in clinical research: public health and social justice imperatives

Abstract

It is well established that demographic representation in clinical research is important for understanding the safety and effectiveness of novel therapeutics and vaccines in diverse patient populations. In recent years, the National Institutes of Health and Food and Drug Administration have issued guidelines and recommendations for the inclusion of women, older adults, and racial and ethnic minorities in research. However, these guidelines fail to provide an adequate explanation of why racial and ethnic representation in clinical research is important. This article aims to both provide the missing arguments for why adequate representation of racial and ethnic minorities in clinical research is essential and to articulate a number of recommendations for improving diversity going forward.Appropriate racial and ethnic representation and fair inclusion help (1) increase the generalisability of clinical trial results, (2) equitably distribute any benefits of clinical research and (3) enable trust in the research enterprise.

Race-based reporting and participation of Black individuals in registered pain clinical trials, United States, 2000 to 2019

“…13,56 This results from longstanding flaws in research and education that essentialize racial health inequities as arising from genetic variation, rather than as a consequence of differential environmental exposure. 19,64 Reporting race does not necessitate the analysis of trial outcomes by race; indeed, we and others advise against using race to classify diverse clinical or biological outcomes. 68 We do, however, emphasize the importance of maintaining-and increasing-diversity in clinical trials to promote generalizability across people with different experiences of racialization, to ensure the equitable benefits of clinical research, and to increase confidence in biomedical research and healthcare institutions.…”

“…Racial diversity in clinical trials is vital for generalizing results and ensuring equitable benefits to medical advances. 64 However, racial diversity, particularly participation of Black individuals in the United States, may be low in pain clinical trials due to a variety of factors, including distrust in research related to past experimentation, lack of health insurance, comorbidities (used as exclusion criteria in clinical trials), and costs to participate (eg, transportation, parking, and missed work). 8,12,36,57 Demonstrating a commitment to participant diversity in clinical trials, the National Institutes of Health (NIH), US Food and Drug Administration (FDA), Agency for Health Research and Quality, and Centers for Disease Control and Prevention have developed guidelines advocating for greater inclusivity and diversity.…”

“…Racial diversity in clinical trials is vital for generalizing results and ensuring equitable benefits to medical advances. 64 However, racial diversity, particularly participation of Black individuals in the United States, may be low in pain clinical trials due to a variety of factors, including distrust in research related to past experimentation, lack of health insurance, comorbidities (used as exclusion criteria in clinical trials), and costs to participate (eg, transportation, parking, and missed work). 8,12,36,57…”

Diversity and inclusion in clinical trials: Evolution throughout the development of an mRNA COVID-19 vaccine

“…Equitable representation in clinical trials remains essential for the public health sector, particularly for countries with racially pluralistic societies ( 1 ). An understanding of how age, race, gender, underlying medical conditions, and other factors can affect an individual’s response to a particular medication, vaccine, or medical treatment is critical for guiding effective patient healthcare ( 1 , 2 ). Although regulatory efforts have been undertaken to promote clinical study populations that are reflective of population demographics ( 3 – 6 ), racial and ethnic minorities remain largely underrepresented ( 7 , 8 ).…”

Ranking pharmaceutical companies on clinical trial diversity

“…Clinical trial participants are more often male, white, and tend to be younger and healthier than real world patients. This lack of diversity in research can provoke questions about the safety and effectiveness of novel therapeutics in under-represented populations, as well as raising important public health and social justice concerns 4…”