Clinical Trial Basics: Underserved Populations in Clinical Research

What is an underserved population in clinical research?

An underserved population is defined as a community that does not have access to sufficient medical care. These underserved communities typically have:

• Too few primary healthcare providers
• Higher poverty rates
• Higher infant mortality rates
• Higher percentages of elderly persons
• Lower life expectancies

In clinical research, these groups are often underrepresented because of issues such as limited medical outreach, enrollment problems, and lack of access to trial sites.

What are examples of medically underserved populations in clinical research?

Some examples of medically underserved populations include:

• Minority populations: Including racial and ethnic groups - minority populations may face systemic barriers to accessing healthcare and have a higher burden of certain health conditions.
• Individuals living in geographically isolated areas: For e.g., individuals living rural or remote communities, where access to healthcare facilities and medical resources may be limited.
• Individuals from lower-income households: Or individuals with lower levels of education, who may face economic or educational barriers to accessing healthcare and may have limited health literacy.
• Older adults or individuals with disabilities: These individuals may face challenges in accessing healthcare due to mobility limitations, transportation issues, or cognitive impairments.
• Individuals with certain medical conditions or rare diseases: These individuals may have limited treatment options and may be underrepresented in clinical research.
• Children and pregnant women: They may require specialized healthcare and additional safety considerations in clinical research.

It's important to note that medically underserved populations may vary depending on the specific context and location, and it's crucial to consider the unique challenges and needs of each population when designing and conducting clinical research studies.

Why is understanding underserved populations in medical research important?

Understanding underserved populations in medical research is critical because these communities represent a substantial portion of the population that require medical interventions in clinical practice.

Therefore, underserved communities must be included in clinical trials for the results to be representative of the general population. By including diverse populations in clinical research, the findings can be more widely applicable and lead to better-informed healthcare decisions for all patients.

Furthermore, members of these underserved populations may have distinct responses to treatments because of genetic or biological factors. Medical researchers should consider such potential biological differences within the population when assessing treatment outcomes and safety of investigational products.

What are some challenges and barriers to including underserved populations in medical research?

While the general consensus in the clinical research industry is that it is necessary to include underserved populations in medical research, there are several challenges faced in doing so, such as:

• Logistical challenges in recruiting participants from underserved communities.
• Highly restrictive eligibility criteria; some clinical trials may have strict eligibility criteria that exclude individuals from underserved populations. For example, trials may exclude individuals with certain medical conditions or those who are taking certain medications.
• Difficulty in obtaining informed consent from vulnerable groups such as elderly patients or those with cognitive impairments.
• Complex regulatory board frameworks that do not specify how to adequately integrate medically underserved populations in medical research.

What are some potential consequences of excluding underserved populations from medical research?

There are several potential consequences of excluding underserved communities from medical research, including (but not limited to) the following:

• Safety concerns about novel medical interventions for which efficacy and safety/adverse reactions were not assessed in underserved populations
• Deterioration of patient engagement and erosion of trust with underserved populations, who may thus further resist novel treatments or participating in research studies
• Failures to identify clinical variables in underserved populations that may have a connection to an experimental intervention
• Limited fundamental understanding of diseases, especially in observational medical research, which does not account for the relations between a disease (incidence, morbidity, and mortality) and biological and demographic factors of underserved populations