Researchers compared the racial and ethnic representation of participants in food allergen trials with patients who experience food allergies.
There was a significant underrepresentation of Black and Hispanic patients in food allergy immunotherapy trials, further highlighting racial disparities in the inclusion criteria for clinical trials. With a lack of Black and Hispanic participants in food allergy trials, researchers identified a gap in treating large populations for conditions that commonly accompany racial disparities.
“It has been found that prevalence of food allergy in adults is higher among all ethnic and racial groups other than White. Food allergies add psychological stress on patients and caregivers and cause increased financial strain from costs of allergen-free foods. These burdens are compounded in already marginalized and oppressed populations. As such, food allergy interventions are important to closing disparity gaps and should be expected to include these highly affected populations,” wrote authors of a study published in JAMA Network Open.1
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According to Food Allergy Research & Education statistics, around 33 million Americans are living with at least 1 food allergy, while shellfish, milk, and peanuts are the leading causes of US food allergies.2
According to Food Allergy Research & Education statistics, around 33 million Americans are living with at least 1 food allergy. | image credit: Graphicroyalty / stock.adobe.com
While food allergies are prevalent amongst all populations, researchers wanted to better understand how they impacted non-White patients. More specifically, they wanted to further understand Hispanic and Black representation in immunotherapy clinical trials, with the goal of informing providers and researchers of appropriate population considerations in future studies.
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“Physicians’ ability to extrapolate from trial results to their own patients would be dramatically improved if a trial’s participants reflected the product’s intended patient population as accurately as possible,” said Janet Woodcock, MD, Principal Deputy Commissioner at the FDA, in a letter highlighting clinical trial guidelines.
In a systematic review, researchers gathered clinical trial literature that included racial demographics and focused on food allergy immunotherapy trials. They aimed to determine whether or not the racial distribution of study participants in these clinical trials reflected the population of patients who experience food allergies. Study participants were further stratified by pediatric trials, site of study, and National Institutes of Health (NIH) funding.
After review, 26 trials were included in the study and a total of 3689 individuals participated. Most of the study population was White (72%), while 8% was Black, 6% Asian, 6% multiple or other races, 3% Hispanic, and under 1% were American Indian, Native American, or Pacific Islander. Furthermore, researchers noted differences in Black and Hispanic inclusion regarding study site and support funding.1
“In this study, pediatric and adult food immunotherapy clinical trials included predominantly White-identifying participants. Participants identifying as Black or Hispanic were markedly underrepresented in comparison with the general US population,” wrote the authors.1
One of researchers’ most notable findings was in relation to the funding support for each study included in the review. “Black participants made up only 2% of NIH-funded trials but 11% in non-NIH funded studies,” they continued. This is an interesting takeaway from the review as researchers predicted more diversity in NIH-funded trials, instead of the other way around. There is also language in the NIH’s framework that requires researchers to submit inclusion plans to better represent more robust populations.
However, despite NIH guidance, the goal of increasing clinical trial representation continues to prove difficult. In their effort at offering future trial guidance, researchers suggested 11 actionable goals “to improve the efficacy, safety, and effectiveness of novel therapies in the general population…especially important in closing disparity gaps.”1 Some of those actions include establishing predefined metrics for racial representation as well as concerted efforts of community outreach to underserved populations.
All populations are impacted differently when it comes to various illnesses, diseases, and medical complications, and clinical trials are the main avenue for better understanding these populations’ outcomes. This systematic review of representation in food allergy immunotherapy trials is a small example of the larger idea that representation in health care matters and should not be ignored.
“Lack of meaningful inclusion of racial and ethnic groups in clinical trials not only limits the potential benefits and effectiveness of health care interventions but also compounds the broader issue of social injustice and inequity in health care. By ensuring diversity and inclusivity in clinical trials, we can both improve health care outcomes and help increase equity and justice in health care,” concluded authors of the study.1
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