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Clinical Trial Enrollment: Representation from Non-White Participants

ObvioHelath working on clinical trial enrollment of non white participants

Clinical Trial Enrollment

While there's broad agreement on the gap between white and non-white participation in clinical trial enrollment, the number of non-white patients enrolled in clinical trials for general population studies is still quite low.

But why?

We need to zoom out to get to the bottom of the issue; there's a fair amount of context we should highlight. This is especially important if the clinical trial industry is going to move decisively toward a long-term, sustainable solution. For these purposes, it's interesting to hone in on a population rarely discussed when it comes to clinical trial diversity but whose challenges are representative of the broader issues surrounding inclusion.

This post focuses on Indigenous people and extends from there to other underrepresented populations in North America with African, Asian, and Pacific ethnic backgrounds.  

Reasons for Clinical Trial Hesitancy in Ethnic Communities

The recent COVID pandemic highlighted the lack of inclusion of ethnic and Indigenous community (EIC) patients in the fight against chronic health conditions. But, in reality, the problem started much earlier.

As far back as 1946, ethnic and Indigenous groups were subject to unethical and dangerous medical studies that intentionally exposed and infected vulnerable populations in Guatemala to sexually transmitted diseases without the subjects' consent. It is, therefore, no surprise that this led to an atmosphere of mistrust within global Indigenous communities from Australia to the USA and beyond.

Alongside historical mistreatment, indigenous communities have resisted Western clinical trials for various reasons. In some cases, this has been through problems of language, culture, or religion. In others, traveling far distances to clinical trial sites has made it almost impossible for a reasonable percentage of participants to be recruited.  

Some of the reasons are more a matter of practicality. They may even point to systemic issues that we won't dive into in this article but that still play a role—reasons like lack of job security that prevents people from leaving work to participate in on-site trials.

Cancer and Clinical Trial Enrollment Statistics

Systemic inequality and a general mistrust of health professionals often drive the disparity between ethnic minorities and the general population when it comes to health outcomes. Including these minorities in early clinical testing makes it much more likely that the eventual treatment will have a wider and more beneficial effect.

This is obvious when we look at cancer treatment.

Despite some incredible medical advances in the past thirty years, Indigenous peoples have continued to be hard hit by the killer disease. In the U.S., for example, death rates have increased among American Indian and Alaskan Native populations. Meanwhile, participation rates in cancer clinical trials have declined among the same population.

Other ethnic minorities are also poorly represented. In a 2015 cancer study, just 1.8% of the trial participants were Black. This translates to massive underrepresentation of this group, which represented over 14% of the U.S. population at the time. Even more startling is that one in five patients diagnosed with myeloma in the U.S. is Black. Black Americans are more than twice as likely to be diagnosed with blood cancer as white Americans, yet they are so underrepresented in trials so as to be non-existent.

To state the obvious, proportionate representation of Black and Indigenous participants in cancer research trials will give us more data to help improve the efficacy and safety of various treatments. Therapies perform differently according to population type. What may work with one genetic makeup may perform poorly with another. Side effects can also vary wildly according to the individual's genetic markers.

Hence the need for more widespread representation in clinical trials.

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Non-White Participant Data in Clinical Research: The Conundrum

A cohort study from April 2022 shows that out of some 20,000 U.S.-based trials (representing nearly five million enrollees), only 43% reported any ethnicity data. Of those reported studies, nearly 80% were white participants.

As for cancer research trials, a 2014 report from the American Cancer Society concluded that “less than 2% of the National Cancer Institute's clinical trials focus on any race [...] as their primary emphasis.”

There's a similar situation in Australia. A recent cohort study looking at data over 10 years up until 2018 showed that of the 9,206 trials, only 1.5% focused on Aboriginal health. This is despite an almost doubling of the funding for Indigenous research by the Australian National Health and Medical Research Council.

Wider participation from EICs can help to avoid long-term health problems in minority groups and identify potential issues early in the process of developing a treatment. By being as inclusive as possible, healthcare practitioners can ensure that the optimum benefit is delivered to as much of the population as possible.

Core Problems in Ethnic and Indigenous Healthcare

Non-white people still lack access to reasonable healthcare in various parts of the world. Widespread poverty is a major barrier to obtaining proper diagnosis and treatment, but even after diagnosis, many ethnic and Indigenous people face much lower standards of care.

And, this is not just about major disease treatment.

Basic problems such as arthritis, hypertension, and kidney disease are also widespread in EICs across the globe.

All the more reason, therefore, to push for greater ethnic engagement in clinical trials to help develop and improve important treatments.

A History of Mistrust

As highlighted by the Guatemalan example mentioned earlier, for many Ethic and Indigenous Communities (EICs), the idea of Western medical research is associated with significant levels of injustice. As Maori author Linda Tuhiwai Smith explains in her 1999 book,1 "[t]he word itself, 'research,' is probably one of the dirtiest words in the Indigenous world's vocabulary."

A reluctance to participate in Western research studies has naturally evolved from these experiences. Mistrust has been a continuous theme among ethnic and Indigenous peoples in the recent past.

“When working with Indigenous communities, clinical trials may not be plausible mainly due to ethical concerns arising from historical mistrust of researchers and the purposeful exclusion of some individuals from a beneficial intervention.” (Umaefulam, Kleissen and Barnabe, 2022)2

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Cases of Cultural Insensitivity in clinical trial enrollment

Clinical trial enrollment can also reflect deep cultural differences. For example, Indigenous beliefs and traditions, their relationship to nature and natural healing, and general cultural mores all combine to make it more challenging to attract these participants as easily as with white populations.

This is, of course, exacerbated when trials are not transparent. Let’s look at the case of the Havasupai diabetes project in the United States.

In 2004, the Havasupai tribe filed a lawsuit against Arizona State University after finding that their DNA samples, collected for type 2 diabetes research, had been used for several other genetic studies without participant permission. The samples were not only used in other projects but were used for schizophrenia research—ignoring the fact that mental illness is highly stigmatized in the tribe and the research team would likely not have gained consent if the tribe was asked.

The lack of participant data confidentiality, particularly with regard to Indigenous peoples, hardly fostered confidence. In this case, it also demonstrated a fundamental lack of respect for the group’s cultural values.

This experience also soured Native Indian views of research studies in general, which, in turn, served to reinforce mistrust of clinical trial participation. Nearly ten years later, American Indian community health organizations were still trying to deal with the fallout from that one case of patient data abuse.

Why We Need Better All-Round Participation in Clinical Trials

Clinical trials are an essential part of the medical health landscape. They provide a crucial foundation for the provision of all types of healthcare and well-being, from acute to chronic diseases and ailments. Without clinical trials, our medical practitioners lack the crucial data they need to tackle and treat the cases they face every day.

In the case of ethnic minorities, this hits especially hard since the lack of high-quality clinical data often means that the treatment they receive may not be as effective.

Professor Lucinda Platt from the London School of Economics had this to say in late 2021: "Our study, published in early May 2020, was the first to show that almost all minority ethnic groups had higher risks of dying from COVID-19 than the white British majority of a comparable age." This disparity is replicated across many other healthcare issues.

There seem to be many reasons for this, although pinpointing them is often difficult. In the case of the COVID pandemic, the current consensus is that ethnic minorities typically lived in more densely collected households and often had a wider range of comorbidities, which left them open to more serious complications from the pandemic virus.

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How Can We Increase Diversity in Clinical Trial Enrollment?

With such a pressing need for more inclusivity, the medical community needs to think creatively about how to increase diversity in clinical trial enrollment. There is no single solution, but rather the need for a multi-pronged approach.

Trust issues in the time of COVID

Trust in all institutions, particularly medical institutions, plummeted during the pandemic. Widespread conspiracy theories about vaccine safety, combined with the ticking time bomb of civil unrest, police brutality, the rise of the alt-right, and (obviously) the looming danger of COVID-19, have shown us that suspicion and mistrust are far more prevalent today than maybe anyone realized.

Which made it all the more difficult to encourage Black participation in COVID vaccine trials.  

According to an article published in the Journal of Medical Ethics, "Vaccine trials with diverse participants are essential to finding a medicine that works for all people. Yet fewer than half of Black Americans say they would get a COVID-19 vaccine, compared with 63% of Hispanic people…" and "...many Black people say they do not trust the medical establishment because of glaring inequities in modern-day care and historical examples of mistreatment."

How to build trust

A recent report from News Medical highlights the ongoing efforts to repair and rebuild relationships between health institutions and non-white patients. The first steps include improving communications and transparency, but a large part of the effort is focusing on actively engaging community members in the research process.  

For Indigenous people, these ideas include:

By removing a deeply ingrained mistrust of the system and moving the process closer to the community that is being served, the hope is that patient recruitment numbers will improve within the most disadvantaged areas.

For people of color, rebuilding trust may mean using a “trauma-informed lens” and creating a research environment that feels emotionally and physically safe, as well as ensuring that every process is understood for participants at all literacy levels.3 If participants do share their traumas with researchers, access to mental health resources should be provided.

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Improving Access Virtually

Access is another key to boosting Indigenous and minority participation rates.  

With respect to Indigenous people, one example is the inappropriate siting of enrollment centers without recognition of sovereign and geographic tribal boundaries. This lack of perspective has a clear and negative impact on participation, especially if the patients are expected to cross tribal borders.

A study from 2008 that looked at barriers to elder Native participation in cancer clinical trials highlighted that one of the strongest predictors of decreased participation in these trials was the distance to the study site (along with reservations about the long-term confidentiality of data).

In broader terms, situating a trial site far from the participant’s home takes for granted the individual’s ability to take time off work and their willingness to travel, sometimes at great distances or from locations where public transportation may be hard to come by.

Fortunately, more inclusive options are being developed as technology improves, including the use of virtual enrollment. By removing the geographic hurdle, more participation can occur across a wider region.

The ability to conduct virtual pre-screening can significantly improve enrollment rates for research studies. Making registration as easy as possible is a key driver for increasing EIC involvement in clinical trials.

Efforts to rebuild trust, improve access through virtual clinical trials, and create genuine opportunities for community engagement would help improve patient enrollment of EICs in clinical trials of all types and across all countries.

Improved Government Inclusion Efforts

The NIH Revitalisation Act of 1993, covering women and minorities in clinical research, was a direct attempt by the American government to ensure greater participation of diverse populations in clinical trials. The mandate called for investigators "to develop appropriate and culturally sensitive outreach programs and activities" and "include involvement of other organizations, community leaders and informal gatekeepers."  

The results have been mixed.

Efforts to improve EIC participation in U.S. clinical trials are currently underway. President Biden's Cancer Moonshot initiative pushes for a massive and comprehensive expansion of cancer detection and treatment.  

Earlier this year, the U.S. Food and Drug Administration (FDA) issued new draft guidance on how to improve the enrollment of subjects from underrepresented racial and ethnic populations.

"The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health," said FDA Commissioner Robert M. Califf, M.D. "Going forward, achieving greater diversity will be a key focus throughout the FDA."

The document's main recommendation is to ensure that medical product sponsors prepare and submit a Race and Ethnicity Diversity Plan to the FDA as part of their trial creation process. The plan should be submitted early in the clinical development process and based on a template given by the FDA in the guidance document.

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The Crucial Role of Communication in clinical trial enrollment

Effective communication is fundamental to improving ethnic minority enrollment in clinical trials. An obvious barrier is a language.  

This was highlighted in a recent Canadian report that looked at the fact that Indigenous peoples—in this case, the Inuit population—still don’t receive healthcare advice in their own language. This, combined with the scarcity of medical professionals in this Indigenous region of Canada (with one doctor for every three thousand residents), puts a strain on communication.

In 2017, the Canadian federal government allocated almost C$90 million to promote Indigenous languages in the country. Aluki Kotierk, president of Nunavut Tunngavik Incorporated, which administers treaty rights for some 49,000 Inuit citizens, says more can be done: “Canada should promote Indigenous languages in health care services,” said Kotierk, “How important is communication to you when you go see a doctor or nurse?”

Language barriers elsewhere in the world

Language and cultural differences have also been highlighted as obstacles to improving healthcare outcomes among Native peoples in Mexico and South and Central America. In Ecuador, Bolivia, and Guatemala, there is an increasing trend towards Sumak Kawsay, or good living, as one of the pillars of health and well-being. This concept involves all aspects of Indigenous culture, including language.  

In Guatemala, the 2003 Language Law codified the right to access government health services in Indigenous languages. While this legal framework has not been fully implemented in the country, it demonstrates just how important language is to the health and medical access of a population.

This report from The Lancet drives the point home: “The role of language [...] is particularly salient for health interventions involving behavior change or psychosocial support, such as lifestyle interventions for cardiovascular disease […]. In fact, the intentional prioritization of Indigenous language is itself a health intervention.”

What Next for Clinical Trial Enrollment?

Looking at a single non-white population in any predominantly white country can seem trivial from a representation perspective. For example, only 2% of the American population is Indigenous. But, if we’re talking about diversity in clinical trials, it makes more sense to consider the total percentage of all ethnic groups in a national population.

Twenty-five percent of the American population is non-white, which makes the need for higher participation rates in clinical trials much clearer. This figure includes people of African, Indigenous, Asian, Native Hawaiian/Pacific Islander descent (and people who are white plus another race or those from two or more non-white races).  

In other words, 83 million Americans. Add to this the fact that 44% of millennial Americans are non-white, and the message could not be clearer: We need to ensure that research for treatments of diseases affecting all members of the population is safe, effective, and accessible.  

By encouraging more non-white participation in clinical trials, we create opportunities for collecting vital data that could lead to more accurate treatment for millions of people. And, when we consider the state of healthcare access for many of the people underrepresented in clinical health trials, this makes non-white patient enrollment even more critical.

The Future is Virtual

Fortunately, as technology advances, we now have a wider range of tools available with which to try and bridge the gap. Improved education of health practitioners, sophisticated remote telemedicine, and new technologies, such as virtual clinical trials, are all beginning to show promise in this arena. These advancements should be supported and expanded if we hope to address clinical trial diversity.

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ObvioHealth is a new breed of Virtual Research Organization (VRO) leading the long overdue digitization and virtualization of health research to accelerate the development of innovative drugs and devices across the globe. Listed among Inc. 5000’s fastest growing companies for two consecutive years, we are pioneering new ways to collect data, recruit and engage patients, and identify novel outcomes that help to bring life-improving health solutions to market faster. Our patient-centric mobile application and platform enables subjects to use their smartphones as well as wearables and other remote monitoring devices to participate in clinical trials from the comfort of their homes while delivering more cost-efficient and accurate data to sponsors.

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