Clinical trials play a fundamental role in medical research by offering essential insights into the safety and efficacy of novel treatments.
A challenge faced by these pivotal studies is the insufficient representation of certain populations such as Hispanic/Latino individuals. This lack of inclusivity has far-reaching implications for Latino health outcomes.
This 5-minute read will discuss five reasons why increasing Latino representation in clinical research is important.
1. The Hispanic population and their healthcare needs are growing rapidly
From 2022 to 2023, almost 71% of the total population growth in the United States was attributed to the Hispanic community, primarily due to US-born Hispanics rather than immigration.
Reflecting this increase, nearly one-fifth (19.5%) of the U.S. population in 2023 consisted of Hispanics of any race, making them the second largest demographic group after the non-Hispanic White population.
As the Latino population in the United States continues to grow, their healthcare needs also expand. Seven out of ten Hispanic adults say they have seen a doctor or other health care provider in the past 12 months.
According to the FDA, as of 2024, Latino participation in clinical trials remains significantly lower than their representation in the general population.
Therefore, the need for their inclusion in clinical trials to generate reliable data on the efficacy and safety of existing and novel treatments in this population becomes increasingly urgent.
There is no one size that fits all. We must work country by country, region by region, community by community, to ensure the diversity of needs are addressed to support each reality. – Amina J. Mohammed, Deputy Secretary-General, UN
2. Addressing Health Disparities
Importance:
U.S.-born Latinos experience higher rates of certain diseases compared to other ethnic groups. For instance, they have higher incidences of liver and cervical cancers, as well as chronic kidney disease and diabetes. Increased representation in clinical trials helps researchers understand the reasons behind these disparities and develop preventive measures and potentially targeted treatments that are specifically effective for the Latino population.
Example:
If a clinical trial for a new diabetes medication includes a significant number of Latino participants, researchers can gather data on how the drug potentially affects this group differently and which doses are safe and more effective. This can lead to better treatment protocols and disease management tailored to Latino populations.
“Back in the 1990’s we didn’t recruit women into clinical trials and so there was a big struggle to make sure that clinical trials were diverse by gender. Back then the assumption was if you have a bunch of men in the trial, women would react the same way that men do to the medications or the disease pathology would be the same and so, why would you need to have women in trials?”–Dr. Gary Puckrein, President of the National Minority Quality Forum
3. Improving Healthcare Outcomes
Importance:
Participation in clinical trials provides access to new treatments that might not yet be available to the general public. This can be particularly beneficial for communities that suffer from higher disease rates or patients with diseases that don't have a treatment yet. By participating in clinical trials, Hispanics can directly benefit from new treatments and contribute to medical advancements that will improve healthcare outcomes for their communities.
Example:
A clinical trial for a new cancer therapy that includes Latino participants might find the treatment is particularly effective for this group. As a result, this therapy could become a standard treatment option, improving survival rates and quality of life for Latino cancer patients.
4. Ensuring Genetic Diversity
Importance:
Latino populations are genetically diverse, often having mixed ancestry that includes Indigenous, European, and African roots. This genetic diversity can impact how individuals respond to medications and treatments, affecting drug metabolism (how the drug is processed in your body), efficacy (how well the treatment works), and potential side effects. Understanding these genetic differences is crucial for developing personalized medicine. For instance, people with certain genetic markers could potentially require dosage modifications or alternative treatment approaches. This can vary from population to population and from person to person.
“What we’re finding is that we need highly targeted medicine, each individual is different. It has nothing to do with race or anything like that – it’s that everybody’s biology is different.” –Dr. Gary Puckrein, president of the National Minority Quality Forum
Certain genetic variants more common in Latino populations may be associated with increased risk or protection against specific diseases. Studying these variants can lead to better prevention strategies tailored to Latinos.
Example:
A study on liver cancer might find that this condition is more common among Latinos with a specific genetic marker. This information can then be used to monitor high-risk individuals to detect the disease early and to develop treatments that may be more effective for this group or even for a small group of patients within this group.
5. Enhancing Generazability
Importance:
Generalizability refers to the extent to which the results of a study can be applied to a broader population or different situations. If the results of a study can be applied to various groups of people, such as Latinos, Asians, males, females, and elderly patients, then the study is considered to have good generalizability.
Therefore, participant diversity is crucial for understanding how treatments work across different populations. Without a sufficient number of participants from a specific group, it is not possible to determine reliably if the treatment effects apply to that population.
Insufficient representation of Latinos can lead to an incomplete understanding of the safety and effectiveness of new medical products and limit doctors' ability to apply trial findings on Latino patients.
Example:
A clinical trial for a new asthma medication was conducted with a diverse group of participants, including Latinos. The study showed that the medication was less effective among male Latino participants. The sponsor conducted another trial to evaluate a higher dose of the new drug or a combination with an existing one. This subsequent study showed that the response was greatly improved. As a result, doctors now know that Latino patients benefit from higher doses or the combination of drugs. This important discovery would not have been possible without a sufficient number of Latino patients in the study.
Conclusion:
By increasing Latino representation in clinical trials, we can ensure that everyone benefits equally from scientific advances in cancer treatment and other medical fields. This will ultimately improve health outcomes, and quality of life, and reduce healthcare costs associated with morbidity, disability, and mortality for the Latino population.
Before deciding whether to participate in clinical research yourself or on behalf of a loved one, it is important to get informed. Many resources can help with this, such as:
Information on clinical trial participation from the FDA, also available in Spanish.
Patient advocacy organizations in which patients themselves collaborate with research organizations to inform patients of ongoing research studies, including benefits and risks. For example: the patient empowerment network,
Organizations that aggregate information about ongoing clinical trials and provide education to help potential participants understand clinical trial terminology and implications. For example: The Center for Information and Study on Clinical Research Participation (CISCRP)
Programs aimed at increasing the representation of minorities in research such as the "All of Us" research program by the National Institutes of Health. With a focus on diversity, transparency, and accessibility, it is a great way to get involved. Information in Spanish is available.
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