More inclusive recruitment needed to improve quality of asthma, allergy studies
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Common allergic conditions are more prevalent among nonwhite populations, which are underrepresented in many studies. But multiple strategies can improve their recruitment and retention, improving the value of study results, experts wrote.
Historically marginalized populations in the United States have included individuals who identify as Black, Asian, Middle Eastern, North African, Pacific Islander and Native American, as well as individuals of Hispanic or Latino ethnicity, Christopher M. Warren, PhD, assistant professor of preventive medicine and director of population health research at the Center for Food Allergy & Asthma Research at Northwestern University Feinberg School of Medicine, and colleagues wrote in a clinical commentary review published in The Journal of Allergy and Clinical Immunology: In Practice. But the unequal representation of these populations in clinical trials raises questions about the results’ generalizability.
Trial populations
As of 2019, the general population was estimated to be 60% white, 19% Hispanic and 13% Black. Yet in 2020 the FDA approved 53 new drugs based on clinical trials involving 32,000 participants, including more than three-quarters who were white, 11% who were Hispanic and 8% who were Black, Warren and colleagues wrote.
Clinical trial researchers also need to consider socioeconomic status, culture, geography, behavior and language, the authors of the paper wrote, yet recruitment rates for these studies generally are higher among White and more affluent populations — often reflecting the demographics of the researchers themselves, with potential clinical implications.
For instance, Warren and colleagues provided the example of the clinical trials that informed current guidelines recommending that patients with poorly controlled asthma “step-up” to a long-acting beta agonist rather than increasing their inhaled corticosteroid dose did not include many Black patients, and that recommendation has been found to be less effective for Black patients.
Also, despite data showing that half of U.S. children with food allergies are Black, Hispanic or multiracial, the trial supporting the approval of Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp, Aimmune Therapeutics) only included nine Black patients and did not report Hispanic ethnicity.
Addressing recruitment challenges
The authors attributed these discrepancies to insufficient thought among researchers given to their inclusion and exclusion criteria and the expected composition of their study population. Or, the authors continued, the researchers might account for these demographics but not know how to recruit such participants.
Additionally, communities may distrust research recruiters. Potential participants may assume that recruiters are from the police, immigration or social services, which may be seen as a threat.
Many institutions also have poor reputations with neighboring communities. Negative experiences with previous studies and with socioeconomic and health inequities in general have an impact on this distrust as well.
The authors urged researchers to involve key community stakeholders during their study’s planning and design stages, not afterward. In fact, the authors wrote, engagement with community advisory boards representing the population can reduce this distrust and lead to a successful, reciprocal partnership.
To address additional barriers to trial participation, the authors recommended offering transportation, home visits and childcare, along with flexible scheduling and locations. Also, recruitment materials for these populations should be appealing and culturally relevant.
Building rapport
Retention presents additional challenges, especially in longitudinal studies, as Black and Hispanic participants are more likely to drop out or be lost to follow-up than their white counterparts. Transportation, childcare and work obligations are hurdles here too, as well as residential instability.
The authors advised staffing studies with diverse, multilingual personnel who can build rapport with participants. Questions in enrollment surveys asking for potential contacts who will still be in touch with participants in 5 years, regardless of residence, also are helpful, as are locator platforms used by marketing and financial service companies.
The personal touch also is helpful, with hand-written birthday cards and home visits that foster personal connections while confirming participants’ residency.
Plus, the authors wrote that it is inappropriate to expect participants, especially those from marginalized communities, to volunteer their time. Compensation should be fair and consistent with ethical principles of noncoercion as well as attractive and useful.
Instead of gift cards to retailers that may not be available in these communities, the authors recommended timely cash payments. This compensation can be augmented with nonfinancial compensation, such as goods or gift certificates, which can be donated.
Overall, collaborative efforts are key to maximizing the knowledge learned from studies, according to Warren and colleagues.
“When designing and implementing human subject research studies and analyzing the data generated from these studies, it is essential for researchers to consider the impact of their methods on both the study participants as well as the study’s potential to validly inform clinical care and advance public health more broadly,” they wrote. “In the specific fields of allergy, asthma and other immune-mediated disease, which disproportionately impact historically marginalized populations in the U.S., it is especially important that researchers thoughtfully engage affected communities and strive to develop sustainable, mutually beneficial research partnerships.”