7 Challenges Linked to Lack of Racial Diversity in Preclinical & clinical Research and The Need to Source for Biospecimens Globally
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 will have to take the drugs that are approved from the trials, and that right there is a problem that needs to be addressed.
Incidence, symptoms and response to treatment of chronic conditions such as cancer, diabetes, and heart disease vary across racial and ethnic lines. When clinical studies fail to represent this reality, the management of these conditions are likely to flop especially in the underrepresented groups. This article discusses 7 challenges that accrue from a lack of racial diversity in preclinical research (1) and thereby underscores the need to source biospecimens globally.
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. Race and ethnicity also affect lived experiences in terms of socio-economic status and educational attainment, all which appear to be related to elevated blood pressure and cardiovascular risk. Such factors undermine the generalizability of clinical research findings.
2. 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.
3. Hinders innovation in treatment interventions
Racial and ethnic representation in clinical trials allows greater opportunity to explore the variation 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. For example, the discovery of PCSK9 mutations in black subjects transformed our understanding of cholesterol homeostasis and which led to the discovery of better treatment options for atherosclerotic cardiovascular disease. (5)
4. 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.
5. 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.
6. 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)
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, thy are less than 3% of participants in clinical studies. (8) Such racial disparities in clinical research increases the gap in health disparities. Unfortunately, racial and ethnic differences are related to socio-economic status.
“Achieving health equity requires valuing everyone equally with focused and ongoing societal efforts to address avoidable inequalities, historical and contemporary injustices, and the elimination of health and health care disparities” CDC, 2020 (9).
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.
References
National Academies of Sciences, Engineering, and Medicine; Policy and Global Affairs; Committee on Women in Science, Engineering, and Medicine; Committee on Improving the Representation of Women and Underrepresented Minorities in Clinical Trials and Research; Bibbins-Domingo K, Helman A, editors. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington (DC): National Academies Press (US); 2022 May 17. 2, Why Diverse Representation in Clinical Research Matters and the Current State of Representation within the Clinical Research Ecosystem. Available from: https://www.ncbi.nlm.nih.gov/books/NBK584396/
Bothwell, L. E., Greene, J. A., Podolsky, S. H., & Jones, D. S. (2016). Assessing the Gold Standard--Lessons from the History of RCTs. The New England journal of medicine, 374(22), 2175–2181.
Beglinger C. (2008). Ethics related to drug therapy in the elderly. Digestive diseases (Basel, Switzerland), 26(1), 28–31.
Jamison, D. T., Summers, L. H., Alleyne, G., Arrow, K. J., Berkley, S., Binagwaho, A., Bustreo, F., Evans, D., Feachem, R. G., Frenk, J., Ghosh, G., Goldie, S. J., Guo, Y., Gupta, S., Horton, R., Kruk, M. E., Mahmoud, A., Mohohlo, L. K., Ncube, M., Pablos-Mendez, A., … Yamey, G. (2013). Global health 2035: a world converging within a generation. Lancet (London, England), 382(9908), 1898–1955.
Warden, B. A., Fazio, S., & Shapiro, M. D. (2020). The PCSK9 revolution: Current status, controversies, and future directions. Trends in cardiovascular medicine, 30(3), 179–185.
GlobalData. Increased use of virtual trials has contributed to improved patient accrual rates, says GlobalData. 2021. https://www.globaldata.com/increased-use-virtual-trials-contributedimproved-patient-accrual-rates-says-globaldata/
AHRQ (Agency for Healthcare Research and Quality). AHRQ Policy on the Inclusion of Priority Populations in Research. 2021. https://www.ahrq.gov/topics/individuals-special-health-care-needs.html#:~:text=The%20AHRQ%20Policy%20on%20the%20Inclusion%20of%20Priority,and%20justification%20is%20provided%20that%20inclusion%20is%20inappropriate
Borno, H., George, D. J., Schnipper, L. E., Cavalli, F., Cerny, T., & Gillessen, S. (2019). All Men Are Created Equal: Addressing Disparities in Prostate Cancer Care. American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 39, 302–308.
CDC. Disparities. 2020. https://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities