The latest U.S. Census results revealed a 276 percent increase in the multiracial population over ten years, rising from 9 million in 2010 to 33.8 million in 2020. As more Americans self-identify as multiracial, accurately classifying them in clinical trials becomes increasingly important. Including diverse study participants helps ensure that medical research applies to everyone, making the results more useful and accurate. But could there be more precise ways to achieve truly inclusive and effective research?
“Typically when we are categorizing race and ethnicity and clinical trials, there are some very discrete buckets, for example, native Hawaiian or Pacific Islander, Black or African-American, white,” Monique Gary, MD, a Pennsylvania-based breast cancer surgeon, explained to BlackDoctor.org. “The current method of identifying mixed race individuals is by allowing them to select multiple options from the standardized list,” Dr. Gary continued, referring to the Office of Management and Budget’s (OMB) data collection parameters.
“The categories as they stand, because they’re self-designated I suspect that some people; its just a question of how they categorize themselves,” oncologist, Andrew Hertler, MD, told BlackDoctor.org, “and so it makes interpretation of the results somewhat challenging, not to mention the fact that unfortunately minority groups are very much underrepresented in clinical trials, which is a big problem.”
Classifying Race in Clinical Trials: Why it Matters
Health disparities among certain races are highly prevalent. For example, Black Americans, with higher rates of hypertension and diabetes, experience elevated rates of specific diseases and varying responses to treatments.
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Despite these disparities, minority participation in clinical trials remains low. This underrepresentation can result in data that does not accurately represent most races, potentially leading to treatments that are less effective or have adverse events (AEs) among minorities. Addressing this gap is crucial for developing equitable healthcare solutions.
“It isn’t ‘woke’ to ask these questions,” Dr. Gary told BlackDoctor.org. “We understand that clinical trial participation is low in Black and Hispanic individuals specifically, and this can have implications for treatment and response. Equitable representation can only be assured by prioritizing inclusion. This is the true strength of diversity, equity, and inclusion in biomedical research, and this should not be erased.”
Numerous factors, including socioeconomic challenges, health disparities, and historical mistrust and distrust of the medical field, contribute to the underrepresentation of racial and ethnic groups in clinical studies. This lack of diversity can lead to inequities in healthcare outcomes and limit the effectiveness of treatments across communities. But there’s more to it.
“I think what’s important to note is that while we understand race to be a social construct, ancestry is important in understanding, both genetic and epigenetic changes, and in classifying research participants,” Dr. Gray explained.
How Genomic Profiling Works
Improving the accuracy and inclusiveness of clinical trials requires a few strategies. Of course, allowing participants to self-identify race can provide more detailed and reflective data and acknowledges the complexity of racial and ethnic identities, but there are additional options.
“There’s very good reasons why, based on inherited patterns, diseases might occur with different frequency and respond differently to drugs. I think the long-term answer is probably going to be genomic profiling of the patients themselves, rather than looking at subgroups,” Dr. Hertler explained, noting the steady increase in the number of people identifying as multiracial in indicated by U.S. Census data.
“In my own field of oncology, we now advocate—I’m not saying it’s always done—genomic profiling of every tumor that’s done because it helps us determine what disease it is and what therapy we should use to treat it,” Dr. Hertler said.
“The field of pharmacogenomics helps researchers understand how people react to or metabolize medications. Pharmacogenomics looks at the specific genes driving the enzymes we inherit, which break down drugs,” he explained. “There are people called fast metabolizers and slow metabolizers for different classes of drugs. Classifying people in that way is unfortunately not used very much—but that field is going to burgeon, and take off and we’re going to move into an area of much more customized therapies to patients based upon individual genomic characteristics.”
Dr. Hertler shared that he hopes this will happen over the next ten years but wouldn’t be surprised if pharmacogenomics are much more commonly used within five years. This change is promising for more effective and equitable healthcare, ensuring that treatments are safe and work for everyone, regardless of their racial or ethnic background.
Health outcomes are shaped by a combination of race, genetics, environment, and lifestyle. By embracing diversity and adopting more precise research methods like genomics, we can build a more inclusive medical approach that leads to better, more effective treatments for all.
