Enhancing Diversity in Clinical Trials: Why It Matters for Drug Development
Clinical trials play a vital role in the development of healthcare products, and there is an increasing awareness of the need for more diversity in participant pools. With the recent introduction of draft guidelines by the US Food and Drug Administration (FDA) that make Diversity Action Plans mandatory, we highlight Teva’s efforts in this area and underscore the significance of diversity in drug development.
Did you know that:
Did you know that:
- Local anesthetics have a shorter duration of effectiveness in individuals with red hair.
- Women are more likely to experience adverse side effects from medications due to historical clinical trials being predominantly male-focused.
Clinical trials are essential for advancing medicine. Without these trials and the volunteers who participate, we wouldn’t have treatments for diseases like cancer or vaccines that save lives. They are crucial for developing treatments for various conditions that affect humanity. Simply put, clinical trials drive scientific progress toward better disease management and improved quality of life for those affected.
What is a clinical trial and who participates? These trials are controlled studies conducted by skilled clinicians on volunteers to evaluate the safety and effectiveness of potential new drugs or medical devices. However, clinical trials aren't limited to testing medications—they also investigate methods for detecting or treating serious diseases and chronic conditions.
Regulatory bodies such as the FDA and the European Medicines Agency (EMA) rely on data from clinical trials to approve treatments, ensuring they meet safety and efficacy standards.
So, who typically participates in these trials? Predominantly white individuals.
Diversity in Clinical Trials: The Statistics Since the late 1990s, the number of countries contributing to the clinical trial data used by the FDA to approve drugs has nearly doubled, although 57% of this data still comes from US-based study sites. However, participant diversity has not changed significantly. In the late 1990s, 92% of trial participants were white, a figure that dropped to 86% two decades later, and to 75% in 2020.
In 2020, the breakdown of clinical trial participants was as follows: 75% White, 11% Hispanic, 8% Black or African American, and 6% Asian. Furthermore, only 30% of participants were over 65 years old, and more than half were located in the US.
Why does participant diversity matter? Clinical trials help us understand whether a drug is safe and effective and the potential side effects it may cause. However, these effects can vary based on factors like ancestry, age, and gender. Trials that include diverse populations are more likely to yield results that are applicable to a wider range of individuals. For example, in a study on multiple sclerosis (MS), Black patients had a shorter response duration to therapy than White patients. Additionally, people with red hair experience shorter-lasting effects from local anesthetics, and women may face more adverse medication effects due to dosing based on trials predominantly involving men.
Without diverse representation, clinical trial results may not be universally applicable, potentially leading to ineffective treatments or unforeseen side effects.
Diversity extends beyond ethnicity. Diversity encompasses more than ethnicity; it includes various personal, physical, social, and economic factors. These range from appearance to socioeconomic status, education, religion, and language. Increasing diversity in clinical trials is not just about ethnicity but also about including individuals from all walks of life.
Ethnic minorities are significantly underrepresented in clinical trials, as are other groups—often those who suffer from higher rates of disease and comorbidities, and who may be more likely to need the very medications being tested.
Who is excluded? Research shows that underrepresented groups in clinical trials include the elderly, children, the LGBTQ+ community, and pregnant women or those planning pregnancy. Other excluded groups include non-native speakers, the unemployed, low-income individuals, those in alternative housing or remote locations, and people with obesity, mental health conditions, learning disabilities, physical disabilities, multiple health conditions, or addictions.
These groups are more likely to use medications, yet they are largely absent from clinical trials assessing these treatments.
Why the exclusion? There are numerous barriers to the participation of certain groups in clinical trials. From eligibility criteria to the locations of trial sites, various factors contribute to underrepresentation. For example, trial sites are often situated in areas that lack ethnic or social diversity, and healthcare professionals may not have the cultural competence or language skills needed to engage diverse populations.
Additionally, many people face barriers to healthcare access due to systemic inequalities. This is compounded by a lack of trust in the healthcare system, particularly among low-income individuals. For example, only 59% of Black adults in the US trust doctors, compared to 78% of White adults. In the UK, vaccine hesitancy is higher among Black and Bangladeshi/Pakistani populations, and in Australia, Indigenous communities are more likely to leave the hospital against medical advice.
New Guidelines: Diversity Action Plans Recognizing the need for greater diversity, the FDA has introduced new guidelines requiring sponsors to submit Diversity Action Plans for certain clinical studies. These plans outline strategies for enrolling participants from diverse age groups, ethnicities, races, and genders, aiming to ensure diversity is prioritized from the earliest stages of clinical development. Similarly, the EMA has introduced regulations requiring justification for non-representative practices in clinical trials.
Teva’s Commitment to Diversity At Teva, a diversity plan is created at the beginning of every trial program, setting goals for the inclusion of underrepresented populations. Efforts are made to identify and select sites that can access these populations, and diversified vendors may be used to include minority-focused sites in global studies.
Our approach goes further, as a recent Deloitte report highlights that limited information about clinical trials and not being invited to participate are major barriers to diverse involvement. At Teva, we recognize that many patients, particularly from racially and ethnically diverse backgrounds, are unaware of clinical trials. Therefore, we engage with community leaders and organizations to understand and address the challenges these groups face in accessing healthcare and trials.
“We are designing trials to make them more accessible to diverse populations, focusing on patient-centered development,” says Jessica Marer, Associate Director of Clinical Trial Planning at Teva. “Understanding the local population helps us build trials with flexibility, improving access for everyone.”
Teva also provides cultural competency training for clinical sites and offers multilingual resources and interpreters to overcome language barriers and ensure all participants fully understand and feel comfortable with the study.
"As we strive for equitable benefit sharing with the communities we serve, we can actively address healthcare access disparities," says Melissa Grozinski-Wolff, Senior Director of Clinical Operations at Teva.
Increasing diversity in clinical trials is not just about assessing how different groups respond to medicines; it's simply the right thing to do.
What is a clinical trial and who participates? These trials are controlled studies conducted by skilled clinicians on volunteers to evaluate the safety and effectiveness of potential new drugs or medical devices. However, clinical trials aren't limited to testing medications—they also investigate methods for detecting or treating serious diseases and chronic conditions.
Regulatory bodies such as the FDA and the European Medicines Agency (EMA) rely on data from clinical trials to approve treatments, ensuring they meet safety and efficacy standards.
So, who typically participates in these trials? Predominantly white individuals.
Diversity in Clinical Trials: The Statistics Since the late 1990s, the number of countries contributing to the clinical trial data used by the FDA to approve drugs has nearly doubled, although 57% of this data still comes from US-based study sites. However, participant diversity has not changed significantly. In the late 1990s, 92% of trial participants were white, a figure that dropped to 86% two decades later, and to 75% in 2020.
In 2020, the breakdown of clinical trial participants was as follows: 75% White, 11% Hispanic, 8% Black or African American, and 6% Asian. Furthermore, only 30% of participants were over 65 years old, and more than half were located in the US.
Why does participant diversity matter? Clinical trials help us understand whether a drug is safe and effective and the potential side effects it may cause. However, these effects can vary based on factors like ancestry, age, and gender. Trials that include diverse populations are more likely to yield results that are applicable to a wider range of individuals. For example, in a study on multiple sclerosis (MS), Black patients had a shorter response duration to therapy than White patients. Additionally, people with red hair experience shorter-lasting effects from local anesthetics, and women may face more adverse medication effects due to dosing based on trials predominantly involving men.
Without diverse representation, clinical trial results may not be universally applicable, potentially leading to ineffective treatments or unforeseen side effects.
Diversity extends beyond ethnicity. Diversity encompasses more than ethnicity; it includes various personal, physical, social, and economic factors. These range from appearance to socioeconomic status, education, religion, and language. Increasing diversity in clinical trials is not just about ethnicity but also about including individuals from all walks of life.
Ethnic minorities are significantly underrepresented in clinical trials, as are other groups—often those who suffer from higher rates of disease and comorbidities, and who may be more likely to need the very medications being tested.
Who is excluded? Research shows that underrepresented groups in clinical trials include the elderly, children, the LGBTQ+ community, and pregnant women or those planning pregnancy. Other excluded groups include non-native speakers, the unemployed, low-income individuals, those in alternative housing or remote locations, and people with obesity, mental health conditions, learning disabilities, physical disabilities, multiple health conditions, or addictions.
These groups are more likely to use medications, yet they are largely absent from clinical trials assessing these treatments.
Why the exclusion? There are numerous barriers to the participation of certain groups in clinical trials. From eligibility criteria to the locations of trial sites, various factors contribute to underrepresentation. For example, trial sites are often situated in areas that lack ethnic or social diversity, and healthcare professionals may not have the cultural competence or language skills needed to engage diverse populations.
Additionally, many people face barriers to healthcare access due to systemic inequalities. This is compounded by a lack of trust in the healthcare system, particularly among low-income individuals. For example, only 59% of Black adults in the US trust doctors, compared to 78% of White adults. In the UK, vaccine hesitancy is higher among Black and Bangladeshi/Pakistani populations, and in Australia, Indigenous communities are more likely to leave the hospital against medical advice.
New Guidelines: Diversity Action Plans Recognizing the need for greater diversity, the FDA has introduced new guidelines requiring sponsors to submit Diversity Action Plans for certain clinical studies. These plans outline strategies for enrolling participants from diverse age groups, ethnicities, races, and genders, aiming to ensure diversity is prioritized from the earliest stages of clinical development. Similarly, the EMA has introduced regulations requiring justification for non-representative practices in clinical trials.
Teva’s Commitment to Diversity At Teva, a diversity plan is created at the beginning of every trial program, setting goals for the inclusion of underrepresented populations. Efforts are made to identify and select sites that can access these populations, and diversified vendors may be used to include minority-focused sites in global studies.
Our approach goes further, as a recent Deloitte report highlights that limited information about clinical trials and not being invited to participate are major barriers to diverse involvement. At Teva, we recognize that many patients, particularly from racially and ethnically diverse backgrounds, are unaware of clinical trials. Therefore, we engage with community leaders and organizations to understand and address the challenges these groups face in accessing healthcare and trials.
“We are designing trials to make them more accessible to diverse populations, focusing on patient-centered development,” says Jessica Marer, Associate Director of Clinical Trial Planning at Teva. “Understanding the local population helps us build trials with flexibility, improving access for everyone.”
Teva also provides cultural competency training for clinical sites and offers multilingual resources and interpreters to overcome language barriers and ensure all participants fully understand and feel comfortable with the study.
"As we strive for equitable benefit sharing with the communities we serve, we can actively address healthcare access disparities," says Melissa Grozinski-Wolff, Senior Director of Clinical Operations at Teva.
Increasing diversity in clinical trials is not just about assessing how different groups respond to medicines; it's simply the right thing to do.
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