Why Diversity in Clinical Trials is So Important

Clinical trials are essential for the development of health care products, and it is increasingly recognized that there is a need for more diversity in trial participation. With new draft Food and Drug Administration (FDA) guidelines in the US to make Diversity Action Plans mandatory, we showcase Teva’s work in this space and highlight its importance in drug development.

Did you know that:

Local anaesthetic works for a shorter time on people with red hair.

Women are more likely to suffer from some adverse side effects of medications because medicine dosages have historically been based on clinical trials conducted in men.

Clinical trials are essential for the development of medicines. Without clinical trials and the volunteers who participate in them, we wouldn’t have treatments for cancer or lifesaving vaccines. In fact, we wouldn’t be able to develop treatments for many of the diseases that negatively affect the human race. It’s quite simple - clinical trials are important for advancing the science towards better management of illnesses and better quality of life for those who suffer from them.

What is a clinical trial and who takes part?

These trials are controlled research studies performed by skilled clinicians with people who volunteer to evaluate the safety and efficacy of potential new drugs or medical devices. But it’s not just about testing medicines. Some clinical trials test ways to find or treat life-threatening diseases and chronic conditions.

Regulatory organizations including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) rely on the results of clinical trials carried out by pharmaceutical companies to decide whether to approve treatments to be used in accordance with the prescribing information for each respective product.

So, who are these clinical trial participants? Mainly white people, it turns out.

Clinical trial diversity: the stats

Since the late 1990s, the number of countries contributing to the clinical-trial data used by FDA to approve drugs has almost doubled (even though 57% of the results still come from study sites in the US). But the diversity of participants taking part hasn’t changed very much. Back then, 92% of the participants in these trials were white – 20 years later that figure was 86%.

And in 2020? 75%.

In fact, in all the medications approved by the FDA in 2020, the clinical trial participants were comprised of: 75% White, 11% Hispanic, 8% Black African American, 6% Asian. Only 30% of the participants were over 65 years of age and more than half of the patients were located in the US.

Why does it matter who participates in these trials?

We depend upon the available research to know that a drug could be safe and effective, and the likelihood of it causing side effects. But the nature of those effects can vary between people of different ancestry. Some medicines may work in different ways in different population groups and in different ages, genders, etc. Trials that represent the intended patient population will better predict the results and better predict the outcomes for more people if the study population is more diverse.

For example, in one study in patients with multiple sclerosis (MS), Black people's response to therapy did not last as long as White people’s response. Local anaesthetic works for a shorter time on people with red hair. It’s believed that women are more likely to suffer from some adverse side effects of medications because medicine dosages have historically been based on clinical trials conducted in men. Being able to assess how different groups respond to different medicines is key to treating conditions.

When clinical trials don’t include a representative sample of the population, the results may not apply to everyone equally, which can lead to ineffective treatments, unexpected side effects and unexplored potential.

But it’s not just about ethnicity.

Diversity means more than just your ethnic background – it also includes personal, physical, social and economic circumstances, everything from what you look like to where you live, from how much money you make to how you spend it, the school you go to, how you worship and the language you speak.

Bringing diversity into clinical trials means more than just increasing the pool of ethnic groups represented. It means including people from all different walks of life.

It’s clear from the statistics that ethnic groups are massively under-represented when it comes to clinical trials. And so are many other groups – ironically, often the groups who have a higher incidence of a disease and comorbidities (more than one chronic condition), who may have a higher chance of being prescribed the very medicines that treat these conditions.

Who is being excluded?

Research shows that under-represented groups in clinical trials include the old and the young, the Lesbian, Gay, Bisexual and Transgender (LGBT+) community and pregnant women or those of child-bearing age that plan to get pregnant. They include those who don’t speak the primary language of the country, who are unemployed or on low income, in alternative housing circumstances or remote locations. They also include those who are obese, have mental health conditions, learning disabilities, physical disabilities, multiple health conditions, or addictions.

These groups take disproportionately more medicines, but they are largely not involved in clinical trials to assess them.

Why?

There are many reasons why certain groups are under-represented in trials. From setting the eligibility criteria to the sites who conduct the trials, there are barriers at every step of the process. Take the trial sites for example, often located in areas that are not ethnically or socially diverse. Or the health care professionals who staff them, who may not have the language skills or appreciation for the diverse cultures represented in the local clinical population.

Take the patients themselves. Around the world, there are people who are shut out from or have limited access to primary healthcare systems. This has its roots in the inequalities of the world we live in. Research shows that structural inequalities in our communities cause disparities in healthcare. This is something that the medical community is starting to look at and ask, what can we do?

But it’s not just about being shut out from healthcare – it’s also about mistrusting the health system itself. When you look at the statistics, it’s clear that low-income respondents express much greater dissatisfaction with healthcare than middle income respondents.

In the US only 59% of Black adults as opposed to 78% of White adults have been found to trust doctors. Hesitancy to take the COVID-19 vaccine is highest among Black and Bangladeshi/Pakistani populations in the UK. In Australia, the indigenous community is six times more likely than the White community to leave the hospital against medical advice. 

New guidance: Diversity Action Plans

It’s recognized there is a growing need for diversity in this area. In the US, new FDA guidance provides details on Diversity Action Plans required for certain clinical studies. This guidance requires sponsors to submit detailed Diversity Action Plans outlining strategies to enroll a broader range of participants across age, ethnicity, race and sex, aiming to hold sponsors accountable and ensure that diversity is considered from the earliest stages of clinical development. Meanwhile, in Europe, the EMA has a guiding Clinical Trial Regulation explicitly requiring justification of any non-representative procedures.

“This isn’t just a scientific issue, it’s a matter of equity and fairness,” says Melissa Grozinski-Wolff, Senior Director Clinical Operations at Teva. “Everyone deserves access to safe and effective treatments, regardless of their race or ethnicity, gender or age.”

Teva’s work in this space

A diversity plan will be created at the start of every trial program at Teva, indicating the percentage goal of underrepresented populations that will be included across the studies. Efforts will then be made to identify and select sites that have access to the targeted patient population. Should additional support be needed, this may be provided through diversified vendors who specialize in clinical sites treating minorities so these sites can be included in global studies.

But our work goes much deeper than this. According to a recent Deloitte report, Enhancing clinical trial diversity, the top barriers to diverse participation in clinical trials were limited information about clinical trials and not being asked to participate. At Teva we know that many patients lack general awareness of clinical trials, and that this is particularly evident among racially and ethnically diverse patient populations. So it is essential that we engage with community leaders and organizations to better understand the unique 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, Clinical Trial Planning at Teva. “When we talk about innovative design and how we build our studies, part of that is understanding the local population so we can build trials with flexibility to improve access for everybody. For example, sending a medical practitioner on a home visit if access to the clinical site is challenging. We also use technology to improve accessibility by regularly updating participants with appointment, medication and diary reminders.”

Training modules are provided to our clinical sites to equip our teams with the cultural competency and sensitivity skills needed to work with diverse populations. We recognize that language barriers and other communication challenges can significantly impact participation, so we aim to provide resources including translated materials, multilingual staff and interpreters to ensure that all potential participants fully understand the study and feel comfortable engaging.

“As we strive for equitable benefit sharing with the communities we serve, we can actively address the disparities in access to healthcare,” says Melissa.

Bringing greater diversity into clinical trials is an important way to assess how different groups respond to different medicines, which is key to treating conditions. But it’s not just about that. Clinical trial diversity is simply the right thing to do.

NPS-ALL-NP-01411-NOVEMBER-2024

---

Read more

• Discover the 3 biggest elements shaping clinical diversity today

• “We all deserve to feel like we belong”: find out why diversity is so important at Teva

• Want to join our great team? Read more about a career at Teva