GITNUXREPORT 2025

Clinical Trial Diversity Statistics

Clinical trials underrepresent minorities, women, and underserved populations worldwide.

Jannik Linder

Co-Founder of Gitnux, specialized in content and tech since 2016.

First published: April 29, 2025

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Statistic 1

The representation of women in clinical trials for neurological conditions such as Alzheimer’s is only around 35-40%, whereas they make up the majority of disease prevalence

Statistic 2

Less than 10% of clinical trial participants are from racial and ethnic minorities

Statistic 3

African Americans constitute approximately 13% of the US population but only about 5% of clinical trial participants

Statistic 4

Hispanic/Latino populations are underrepresented in clinical trials, making up about 1-2% of participants despite being 18% of the US population

Statistic 5

Only 4-5% of clinical trial participants are Asian Americans, despite making up about 6% of the US population

Statistic 6

Women comprised approximately 45% of clinical trial participants in recent studies, which is below the equitable representation goal of 50%

Statistic 7

Racial and ethnic minorities face barriers such as mistrust, logistical issues, and lack of awareness that contribute to trial underrepresentation

Statistic 8

Children and adolescents are often underrepresented in clinical trials, comprising less than 20% of pediatric trial participants

Statistic 9

Black participants are three times more likely to be diagnosed with hypertension compared to white participants but are underrepresented in hypertension trials

Statistic 10

Clinical trial enrollment of Latinx populations is approximately 3%, significantly below their population representation

Statistic 11

The participation rate of Indigenous peoples in clinical trials is very limited, often less than 1%, due to geographic and cultural barriers

Statistic 12

The COVID-19 pandemic highlighted disparities, with minority groups being less likely to participate in vaccine trials, due to distrust and access issues

Statistic 13

Women are often underrepresented in cardiovascular trials, comprising less than 40% of participants in many studies, although they represent over 50% of CVD cases

Statistic 14

African descent populations have higher genetic susceptibility to certain diseases, yet their inclusion in relevant clinical trials remains low

Statistic 15

Regulatory agencies like FDA and EMA have set targets for diversity in clinical trials, but actual enrollment often falls short of these goals

Statistic 16

The cost of recruiting diverse populations can be up to 25% higher than recruiting from majority populations, impacting trial budgets

Statistic 17

Community engagement programs can increase minority participation in clinical trials by over 20%, demonstrating the importance of outreach

Statistic 18

In 2020, only 27% of publicly funded clinical trials reported racial and ethnic diversity data, indicating underreporting issues

Statistic 19

Diversity in clinical trial leadership and investigators is also limited, with minorities holding only about 10% of principal investigator roles

Statistic 20

The underrepresentation of minorities in trials is linked to disparities in health outcomes, as trial results may not be generalizable to diverse populations

Statistic 21

Language barriers can reduce trial participation among non-English speakers; providing multilingual materials increases enrollment by 15-20%

Statistic 22

Women of reproductive age often face exclusions from early-phase trials due to safety concerns, limiting data on drugs' effects on female populations

Statistic 23

Minority participants are more likely to drop out of clinical trials due to mistrust, logistical challenges, and perceived discrimination, with dropout rates up to 30%

Statistic 24

Incorporating community advisory boards in trial planning increases minority engagement by over 25%, improving trial relevance and retention

Statistic 25

The FDA’s Action Plan for the Increase and Support of Diversity in Clinical Trials aims to improve minority representation by 2025, but progress has been slow, with many trials still lacking diversity

Statistic 26

In oncology, Black patients are underrepresented at less than 10% in trial enrollment despite accounting for 15-20% of cancer cases

Statistic 27

Genetic research indicates that pharmacogenomic responses vary significantly across different racial and ethnic groups, which makes diverse trial participation crucial for personalized medicine

Statistic 28

Implementing targeted outreach campaigns in minority communities has increased trial enrollment by up to 15% over standard recruitment methods, emphasizing the importance of cultural tailoring

Statistic 29

The median age of clinical trial participants is often skewed toward younger adults, with older adults (65+) comprising less than 20%, affecting generalizability to aging populations

Statistic 30

Language and literacy barriers substantially reduce participation among non-English speaking populations, notably impacting trial diversity

Statistic 31

Minority populations are underrepresented even in trials for chronic diseases that disproportionately affect them, like diabetes and hypertension, leading to less effective treatments

Statistic 32

Institutional efforts to improve diversity include training investigators on cultural competency, which has been shown to improve recruitment and retention metrics

Statistic 33

The proportion of women enrolled in HIV/AIDS clinical trials prior to the 2000s was below 10%, but efforts have increased their participation, currently around 30-40%, although still below disease prevalence

Statistic 34

Access to trial sites influences participation; patients living more than 50 miles from site are 30% less likely to enroll, highlighting geographic disparities

Statistic 35

In some therapeutic areas, such as oncology, minority participation is slightly higher but still below their disease burden

Statistic 36

Participants with higher socioeconomic status are more likely to enroll in clinical trials, which can lead to socioeconomic bias in trial outcomes

Statistic 37

African Americans are less likely to be aware of ongoing clinical trials, with awareness levels as low as 20-30%, affecting participation rates

Statistic 38

The racial minority status affects the likelihood of trial participation independently of education and income levels, underscoring systemic issues

Statistic 39

The use of real-world evidence (RWE) is growing as a method to supplement clinical trial data, especially to include more diverse populations

Statistic 40

Minority access to trial participation is often limited by lack of healthcare coverage or insurance, impacting socioeconomic inclusion

Statistic 41

Digital health tools and telemedicine are emerging as effective strategies to improve trial diversity, especially among rural and underserved populations

Statistic 42

The FDA has implemented policies to increase diversity in clinical trials, including guidance on inclusivity, since 2016

Slide 1 of 42

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Key Highlights

Less than 10% of clinical trial participants are from racial and ethnic minorities
African Americans constitute approximately 13% of the US population but only about 5% of clinical trial participants
Hispanic/Latino populations are underrepresented in clinical trials, making up about 1-2% of participants despite being 18% of the US population
Only 4-5% of clinical trial participants are Asian Americans, despite making up about 6% of the US population
Women comprised approximately 45% of clinical trial participants in recent studies, which is below the equitable representation goal of 50%
Racial and ethnic minorities face barriers such as mistrust, logistical issues, and lack of awareness that contribute to trial underrepresentation
The FDA has implemented policies to increase diversity in clinical trials, including guidance on inclusivity, since 2016
Children and adolescents are often underrepresented in clinical trials, comprising less than 20% of pediatric trial participants
Black participants are three times more likely to be diagnosed with hypertension compared to white participants but are underrepresented in hypertension trials
Clinical trial enrollment of Latinx populations is approximately 3%, significantly below their population representation
The participation rate of Indigenous peoples in clinical trials is very limited, often less than 1%, due to geographic and cultural barriers
The COVID-19 pandemic highlighted disparities, with minority groups being less likely to participate in vaccine trials, due to distrust and access issues
In some therapeutic areas, such as oncology, minority participation is slightly higher but still below their disease burden

Despite constituting nearly 40% of the U.S. population, racial and ethnic minorities, women, and underserved groups remain critically underrepresented in clinical trials, highlighting urgent gaps in diversity that hinder equitable healthcare progress.

Demographic Representation

The representation of women in clinical trials for neurological conditions such as Alzheimer’s is only around 35-40%, whereas they make up the majority of disease prevalence

Demographic Representation Interpretation

Despite women bearing the brunt of neurological diseases like Alzheimer's, their underrepresentation of just 35-40% in clinical trials suggests we’re still not listening to half the story—and half the patients.

Demographic Representation and Enrollment Barriers

Less than 10% of clinical trial participants are from racial and ethnic minorities
African Americans constitute approximately 13% of the US population but only about 5% of clinical trial participants
Hispanic/Latino populations are underrepresented in clinical trials, making up about 1-2% of participants despite being 18% of the US population
Only 4-5% of clinical trial participants are Asian Americans, despite making up about 6% of the US population
Women comprised approximately 45% of clinical trial participants in recent studies, which is below the equitable representation goal of 50%
Racial and ethnic minorities face barriers such as mistrust, logistical issues, and lack of awareness that contribute to trial underrepresentation
Children and adolescents are often underrepresented in clinical trials, comprising less than 20% of pediatric trial participants
Black participants are three times more likely to be diagnosed with hypertension compared to white participants but are underrepresented in hypertension trials
Clinical trial enrollment of Latinx populations is approximately 3%, significantly below their population representation
The participation rate of Indigenous peoples in clinical trials is very limited, often less than 1%, due to geographic and cultural barriers
The COVID-19 pandemic highlighted disparities, with minority groups being less likely to participate in vaccine trials, due to distrust and access issues
Women are often underrepresented in cardiovascular trials, comprising less than 40% of participants in many studies, although they represent over 50% of CVD cases
African descent populations have higher genetic susceptibility to certain diseases, yet their inclusion in relevant clinical trials remains low
Regulatory agencies like FDA and EMA have set targets for diversity in clinical trials, but actual enrollment often falls short of these goals
The cost of recruiting diverse populations can be up to 25% higher than recruiting from majority populations, impacting trial budgets
Community engagement programs can increase minority participation in clinical trials by over 20%, demonstrating the importance of outreach
In 2020, only 27% of publicly funded clinical trials reported racial and ethnic diversity data, indicating underreporting issues
Diversity in clinical trial leadership and investigators is also limited, with minorities holding only about 10% of principal investigator roles
The underrepresentation of minorities in trials is linked to disparities in health outcomes, as trial results may not be generalizable to diverse populations
Language barriers can reduce trial participation among non-English speakers; providing multilingual materials increases enrollment by 15-20%
Women of reproductive age often face exclusions from early-phase trials due to safety concerns, limiting data on drugs' effects on female populations
Minority participants are more likely to drop out of clinical trials due to mistrust, logistical challenges, and perceived discrimination, with dropout rates up to 30%
Incorporating community advisory boards in trial planning increases minority engagement by over 25%, improving trial relevance and retention
The FDA’s Action Plan for the Increase and Support of Diversity in Clinical Trials aims to improve minority representation by 2025, but progress has been slow, with many trials still lacking diversity
In oncology, Black patients are underrepresented at less than 10% in trial enrollment despite accounting for 15-20% of cancer cases
Genetic research indicates that pharmacogenomic responses vary significantly across different racial and ethnic groups, which makes diverse trial participation crucial for personalized medicine
Implementing targeted outreach campaigns in minority communities has increased trial enrollment by up to 15% over standard recruitment methods, emphasizing the importance of cultural tailoring
The median age of clinical trial participants is often skewed toward younger adults, with older adults (65+) comprising less than 20%, affecting generalizability to aging populations
Language and literacy barriers substantially reduce participation among non-English speaking populations, notably impacting trial diversity
Minority populations are underrepresented even in trials for chronic diseases that disproportionately affect them, like diabetes and hypertension, leading to less effective treatments
Institutional efforts to improve diversity include training investigators on cultural competency, which has been shown to improve recruitment and retention metrics
The proportion of women enrolled in HIV/AIDS clinical trials prior to the 2000s was below 10%, but efforts have increased their participation, currently around 30-40%, although still below disease prevalence

Demographic Representation and Enrollment Barriers Interpretation

Despite clear regulatory goals and the pressing need for representative data, minority and underrepresented groups constitute a mere sliver of clinical trial participants—highlighting that even in the era of personalized medicine, inclusion remains an elusive target often hindered by trust, logistical hurdles, and systemic oversight.

Enrollment Barriers

Access to trial sites influences participation; patients living more than 50 miles from site are 30% less likely to enroll, highlighting geographic disparities

Enrollment Barriers Interpretation

This statistic underscores that when clinical trial sites are out of reach—geographically speaking—so too is access to cutting-edge treatments, spotlighting the urgent need to bridge distance gaps to ensure equitable participation.

Health Disparities and Socioeconomic Factors

In some therapeutic areas, such as oncology, minority participation is slightly higher but still below their disease burden
Participants with higher socioeconomic status are more likely to enroll in clinical trials, which can lead to socioeconomic bias in trial outcomes
African Americans are less likely to be aware of ongoing clinical trials, with awareness levels as low as 20-30%, affecting participation rates
The racial minority status affects the likelihood of trial participation independently of education and income levels, underscoring systemic issues
The use of real-world evidence (RWE) is growing as a method to supplement clinical trial data, especially to include more diverse populations
Minority access to trial participation is often limited by lack of healthcare coverage or insurance, impacting socioeconomic inclusion

Health Disparities and Socioeconomic Factors Interpretation

Despite growing efforts and emerging strategies like real-world evidence, the persistent underrepresentation of minorities and socioeconomically disadvantaged groups in clinical trials highlights systemic inequities that threaten the validity and equity of medical research outcomes.

Innovative Strategies and Technologies for Diversity

Digital health tools and telemedicine are emerging as effective strategies to improve trial diversity, especially among rural and underserved populations

Innovative Strategies and Technologies for Diversity Interpretation

Digital health tools and telemedicine are proving to be the great equalizers in clinical trials, bridging gaps for rural and underserved populations while maintaining rigorous standards—a promising step toward truly diverse and representative research.

Regulatory Policies and Industry Initiatives

The FDA has implemented policies to increase diversity in clinical trials, including guidance on inclusivity, since 2016

Regulatory Policies and Industry Initiatives Interpretation

Despite the FDA's proactive policies since 2016 aiming to diversify clinical trial populations, these statistics reveal that achieving truly representative research remains an ongoing challenge in the pursuit of equitable healthcare.