Why is the Lack of Racial Diversity in Preclinical & Clinical Research a Problem?

Close to 40% of Americans are part of a racial or ethnic minority group. However, most clinical trials for new drugs that are carried out in the US fail to represent this reality. You will find that 80-90% of participants in clinical trials are white. Ultimately, the 40% of the racially diverse population that’s excluded from clinical trials will have to take the drugs that are approved from the same trials.?

Is this even right?

When clinical studies fail to be racially diverse, the underrepresented groups are forced to bear the brunt of ineffective treatments. Or worse still, they may be excluded from new treatments or medical devices that may have otherwise been of benefit to them if they were sufficiently tested in their populations.?

Here are some problems that often arise when there’s a lack of racial and ethnic diversity in clinical trials.

Undermines generalizability of clinical research findings

Randomized controlled trials (RCTs) are the gold-standard for evidence-based medicine, implying that results from RCTs can be generalized to? “all patient populations.” (2) However, this thinking has been challenged as it has now emerged that racial and ethnic groups have certain distinct genetic traits and health circumstances that determine their response to treatment. (3) For example, response to drugs with a narrow therapeutic index such as anticoagulants as well as efavirenz is affected by genetic factors that might be present in some ancestral populations. Such factors undermine the generalizability of clinical research findings.

Results in the loss of billions of dollars?

The United States has witnessed a dramatic change in population health in the last century, which has cut across racial and ethnic boundaries. This has resulted in increased productivity and life expectancy. However, this gain has not been achieved equally across the board and racial and ethnic minorities continue to lag behind in their quest for optimal healthcare (4). To make up for this disparity and its economic impact on our society, the government will eventually have to spend billions of dollars to support the underserved populations.?

Hinders innovation in treatment interventions?

The “heterogeneity of treatment effects” that cut across racial and ethnic boundaries can help us better understand variations in biological processes which in turn may lead to the discovery of new treatment options.

Compounds the problem of low accrual in clinical trials

Low accrual is a leading cause of failure in clinical trials. An analysis by GlobalData. (6) showed that 55 percent of? Phase I–IV clinical trials fail due to low accrual. Boosting participation of racial and ethnic minorities in clinical trials is one way to improve enrolment and adherence to clinical trials.?

Improves access to safe and effective treatments for racial and ethnic minorities

Racial and ethnic minorities are often underrepresented in clinical trials which means that the safety and effectiveness of some treatments are “unproven” in such populations. For example, a drug that was approved by the FDA for HIV PrEP was tested only cisgender men & transgender women in Phase III trials. Consequently, “individuals at risk of HIV-1 from receptive vaginal sex” were excluded from this form of treatment because “the effectiveness of this drug was not tested in that population.” The same may ensue when racial and ethnic minorities are excluded from clinical trials.

Undermines trust in the medical profession

Distrust of the medical profession is a barrier to participation in clinical research, and lack of racial diversity in clinical trials compounds this problem. An example is the infamous series of Tuskegee experiments where black men were deliberately exempted from syphilis treatment. Also, the lack of racial diversity in SAR-CoV-2 clinical trials led to apprehension, mistrust, and poor uptake of the vaccine in certain parts of the world. (7)

Increases the gap in health disparities across racial, ethnic, and socio-economic classes

Poor representation of racial and ethnic minorities in clinical research limits the access of these groups to safe and effective treatments.? For example, black men have a greater chance of developing and dying from prostate cancer. While black males make up about 30% of prostate cancer deaths in the US, they are less than 3% of participants in clinical studies.?

Lack of Racial Diversity in Clinical Research Threatens the Overarching Goals of Clinical Research

Racial and ethnic diversity has become an increasingly important consideration for clinical research. Even though clinical researchers and other stakeholders are more than willing to address the issue, challenges in getting racial and ethnic representation abound. Racial and ethnic minorities are unwilling to participate in clinical research in some instances while in others, they don't have access to the health facilities where clinical trials are carried out. Whatever the case, such barriers undermine the value and obstruct the goals of clinical research.?

Garner Bio Solutions is a biotechnology company that is committed to helping researchers access the best biospecimens that are racially inclusive.? To achieve this goal, Garner Biosolutions has partnered with Indian hospitals that allow them to collect complex samples because they are fully integrated within their labs. Garner Biosolutions prides itself in providing affordable, ethically sourced, traceable, and racially diverse clinical specimens. Contact us today to learn more about what we do and how we can help you get the biospecimens that you need.?

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