Food Allergy Highlights Opportunities for Inclusive, Representative Research Studies

More than 32 million Americans are living with food allergy, a life-changing and potentially life-threatening disease.

Anita Roach M.S.March 22, 2023

Food Allergy Highlights Opportunities for Inclusive, Representative Research Studies.

Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.

Today, we are pleased to welcome a guest article from Anita Roach, M.S., Vice President of Health Equity and Community Engagement at FARE (Food Allergy Research & Education).

More than 32 million Americans are living with food allergy, a life-changing and potentially life-threatening disease. Studies have revealed differences in food allergy outcomes that disproportionately impact Black and Hispanic/Latino communities, as well as households with lower incomes. These disparities include underdiagnosis1, greater risk of severe allergic reaction and subsequent hospitalization and death2,3, and underrepresentation in food allergy clinical trials4.

As the nation’s leading non-profit engaged in food allergy advocacy as well as the largest private funder of food allergy research, FARE (Food Allergy Research & Education) is committed to reducing health inequities in food allergy, including access to research and specialized care. Three years ago, our organization went through a process of listening to patients, health care providers, and health equity stakeholders to begin to collaboratively tackle the crisis of health inequity. In 2021, we launched our social determinants of health-based Health Equity portfolio, which includes our signature initiative, the FARE Community Access Program (CAP), where we work in partnership with local and national organizations to align our common goals to enable greater impact. In 2022, we formalized a dynamic team within our organization dedicated to embedding health equity in all we do.

At the same time, the U.S. Food & Drug Administration (FDA) ramped up efforts around inclusion in clinical trials. In 2022, FDA issued a new draft guidance5 to industry for developing diversity plans to encourage enrollment of more participants from underrepresented racial and ethnic populations into clinical trials. Additionally, the U.S. Department of Health and Human Services’ Diversity in Clinical Trials Initiative addresses barriers preventing diverse groups from participating in clinical trials, and includes public education and outreach campaigns. Industry-wide efforts such as PhRMA’s voluntary principles to enhance clinical trial diversity, and their grant to fund Equitable Breakthroughs in Medicine Development, highlight the importance of community-based infrastructure to improve access to clinical trials for those in historically marginalized communities who want to participate. Collective efforts such as these take time and ongoing resources to create a sustainable approach towards tackling the systemic barriers that often stand in the way of people participating in clinical trials, particularly people from underrepresented communities.

Clinical trials are foundational to the development of novel therapies and interventions. Thus, inclusive research is not just “nice to have.” Diverse clinical trial populations can better reflect the broad patient population that will use new medicines once they are approved, improving health outcomes. Diversity in clinical trials can provide science-based insights into the variable safety and efficacy responses people can have to therapeutic interventions.

Together, patient advocacy groups, industry sponsors, institutional review boards (IRBs) and scientific research teams must partner toward improving clinical trial representation. Here are a few ways6 we can achieve this:

Before a study launches

  • Openly communicate the study’s potential benefits and risks
  • Partner with community advisory councils that represent and engage the target audience
  • Offer seats at the research table and enable patient representatives to weigh in on study protocols and related study materials including informed consent materials
  • Treat patient representatives as experts given their lived experience, taking into account their diverse needs and perspectives in clinical trial design
  • Consider ways to reduce the burden of clinical trial participation
  • Broadening eligibility criteria to increase diversity in enrollment when scientifically and clinically appropriate
  • Present IRB with proposal to provide patients just and fair reimbursement for research participation

During recruitment

  • Use culturally appropriate messaging to elevate the trial’s visibility through social media, community websites, radio, TV, recreational centers and transportation hubs
  • Leverage word-of-mouth communication in places of worship, parent groups, book clubs and other community organizations
  • Invite community leaders to take part in free, multilingual informational sessions with dedicated Q&A periods

After the study

  • Maintain contact with participants and consider whether crossing-over is appropriate for the placebo arm
  • As appropriate, make the study results available and actionable to patients as soon as possible in clear and simple language through various activations, such as engagement events
  • Provide opportunities for feedback and follow up post-study such as exit interviews
  • Nurture relationships beyond study and stay-in-touch beyond the end of the study

More broadly, it is critical to ensure that approved medicines are accessible and affordable for patients, especially as we seek more participation and critical information from under-represented and under-resourced groups in clinical trials. Lastly, diverse clinical and research teams are essential to foster trust between study participants and care providers, which is why efforts like the FARE Diversity Scholars Program are vital beyond any one study.

To learn more about opportunities to partner with FARE in efforts to increase diversity and representation in food allergy research, contact Anita Roach, Vice President of Health Equity and Community Engagement, at


1. Bilaver L, Kanaley M, Fierstein J, Gupta R. (2020) Prevalence and Correlates of Food Allergy Among Medicaid-Enrolled United States Children. Acad Pediatr;21(1):84-92. doi: 10.1016/j.acap.2020.03.005.
2. Gupta R, Warren C, Smith B, Blumenstock J, Jiang J, Davis M, Nadeau K. (2018) The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics;142(6):e20181235. doi: 10.1542/peds.2018-1235.
3. Mahdavinia M, Fox SR, Smith BM, James C, Palmisano EL, Mohammed A, Zahid Z, Assa’ad AH, Tobin MC, Gupta RS. (2017) Racial Differences in Food Allergy Phenotype and Health Care Utilization Among US Children. J Allergy Clin Immunol Pract. Mar-Apr 2017;5(2):352-357.e1
4. Davidson L, Jones B. (2021) The Racial and Ethnic Makeup of Food Allergy Immunotherapy Trials. J Allergy Clin Immunol. 2021 147(2), Feb. 1, 2021 Supplement, AB93. doi: 10.1016/j.jaci.2020.12.354
5. S. Food and Drug Administration. (2022) FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials. Published April 13, 2022. Accessed February 15, 2023.
6. Otado J, Kwagyan J, Edwards D, Ukaegbu A, Rockcliffe F, Osafo N. (2015) Culturally Competent Strategies for Recruitment and Retention of African American Populations into Clinical Trials. Clin Transl Sci;8(5):460-6. doi: 10.1111/cts.12285.

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