Inclusion of special populations in clinical research: important considerations and guidelines

Abstract

Background: Trials that involve human participants call for experiments or observations that are performed in a clinical research setting. Currently, there are over 16,000 clinical trials open in the United States. Despite continuing efforts to include "special populations" in clinical trials, there are gaps in participation for people who are either minors or elderly adults, are from historically under-represented minorities, or live in rural communities. The inclusion of these special populations in clinical trials research is essential for conclusions that benefit all populations. Data suggest that study participation rates for special populations have fallen to levels that could endanger the successful performance of some types of research. This is particularly concerning in the 21st century, where demographic trends in the United States continue to shift towards an older and Hispanic population with fewer rural dwellers. Trends in New Mexico and other minority-majority states mirror many of these shifts. Relevance for patients: In this review, we highlight improvement strategies for enhanced clinical trial participation by members of special populations. Key drivers for disparate clinical trials participation and outcomes often include differences in genetics, physiology, and perceptions of mistrust towards researchers. To overcome these barriers, we focus on best practices in recruitment strategies from the perspectives of the participants, the researchers and the institutions that support clinical trials.

Lessons learned recruiting a diverse sample of rural study participants during the COVID-19 pandemic

“…Rural communities experience significant health disparities ( Knapp, Paavola, Maine, Sorofman, & Politzer, 1999 ); thus, recruiting research participants from rural areas is crucial to understand their experiences and create effective solutions to address their specific health care needs. This paper aimed to contribute to the limited knowledge on effective recruitment strategies in rural areas, by identifying effective recruitment strategies for rural populations that have been underrepresented in clinical research ( Winter et al., 2018 ). We make several recommendations for researchers who seek to recruit rural participants ( Table 2 ).…”

“The Message Is You Don’t Exist”: Exploring Lived Experiences of Rural Lesbian, Gay, Bisexual, Transgender, Queer/Questioning (LGBTQ) People Utilizing Health care Services

“…Broad inclusion criteria were used in this study because the LGBTQ population is known as a "hard to reach population" and according to Bishop et al (2016), recruitment of special populations in rural communities is challenging given geographic distances, transportation barriers, and the low number of eligible participants. Research suggests that study participation rates for special populations have fallen to levels that could endanger the successful performance of some types of research (Winter et al, 2018). Purposive and snowball sampling methods were used to gather data.…”

The Measurement and Conceptualization of Coping Responses in Pediatric Chronic Pain Populations: A Scoping Review

“…In other fields, the use of item content analyses, focus groups, or cognitive interviews has been useful for capturing group differences and patient experiences using particular measures (Beatty and Willis, 2007; Amtmann Crombez et al, 2020). Researchers have also used culture-specific and patient-centered approaches for recruitment to increase the diversity of youth in research (Zamora et al, 2016;Winter et al, 2018). Alternatively, the recruitment of sufficient sample sizes can allow for age, gender, and ethnicity-specific analyses (Winter et al, 2018).…”

“…Researchers have also used culture-specific and patient-centered approaches for recruitment to increase the diversity of youth in research (Zamora et al, 2016;Winter et al, 2018). Alternatively, the recruitment of sufficient sample sizes can allow for age, gender, and ethnicity-specific analyses (Winter et al, 2018).…”