Enhancing Recruitment and Retention of Minority Populations for Clinical Research in Pulmonary, Critical Care, and Sleep Medicine: An Official American Thoracic Society Research Statement

Abstract

Background: Well-designed clinical research needs to obtain information that is applicable to the general population. However, most current studies fail to include substantial cohorts of racial/ethnic minority populations. Such underrepresentation may lead to delayed diagnosis or misdiagnosis of disease, wide application of approved interventions without appropriate knowledge of their usefulness in certain populations, and development of recommendations that are not broadly applicable. Goals: To develop best practices for recruitment and retention of racial/ethnic minorities for clinical research in pulmonary, critical care, and sleep medicine. Methods: The American Thoracic Society convened a workshop in May of 2019. This included an international interprofessional group from academia, industry, the NIH, and the U.S. Food and Drug Administration, with expertise ranging from clinical and biomedical research to community-based participatory research methods and patient advocacy. Workshop participants addressed historical and current mistrust of scientific research, systemic bias, and social and structural barriers to minority participation in clinical research. A literature search of PubMed and Google Scholar was performed to support conclusions. The search was not a systematic review of the literature. Results: Barriers at the individual, interpersonal, institutional, and federal/policy levels were identified as limiting to minority participation in clinical research. Through the use of a multilevel framework, workshop participants proposed evidence-based solutions to the identified barriers. Conclusions: To date, minority participation in clinical research is not representative of the U.S. and global populations. This American Thoracic Society research statement identifies potential evidence-based solutions by applying a multilevel framework that is anchored in community engagement methods and patient advocacy.

The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions

“…The PAC works closely with the Recruitment and Retention Committee to implement strategies to enhance subject recruitment in general, and minorities and adolescents in particular. 21 Some of the steps taken, based in part on PAC recommendations, include (1) using flexible scheduling including evening and weekend appointments, (2) allowing participants to switch sites if they move (eg, graduating high school seniors going to college in another city, see below), (3) combining study appointments with clinical appointments, (4) reimbursing subjects for transportation to the site, and (5) using surveys/procedures that can be done at home to shorten face-to-face visits. We will continue to engage the PAC during later stages of trial implementation and results reporting in the PrecISE Network as resources permit.…”

Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance

“…Some of these challenges remain even in high-income countries. The USA still struggles to recruit minorities into clinical trials to achieve the diversity needed to understand the effect of drugs on its diverse population 31–33. The National Institutes of Health (NIH) in the USA developed a framework to create a large national consortium of cohorts with one million Americans, and identified several challenges that include feasibility, coordination and ongoing funding 29.…”

Equitable Representation of Latinos in Clinical Research Is Needed to Achieve Health Equity in Cancer Care

“…From the health equity perspective, lack of CT participation among under-represented groups reduces opportunities for discovering effects that may be relevant to these groups and their cancer care, often preventing them from getting access to potentially lifesaving cancer treatments. 4,8,9…”

“…From the health equity perspective, lack of CT participation among under-represented groups reduces opportunities for discovering effects that may be relevant to these groups and their cancer care, often preventing them from getting access to potentially lifesaving cancer treatments. 4,8,9 Although Latinos represent 19% of the nation's population, 15 , 7% participate in CTs and only 2% participate in biobanking, resulting in many patients potentially missing out on access to breakthrough treatments. [16][17][18][19][20] The lack of Latinos and other under-represented groups in CTs also hinders the assessment and understanding of potential differences in drug efficacy and tolerability among diverse populations.…”

“…[16][17][18][19][20] The lack of Latinos and other under-represented groups in CTs also hinders the assessment and understanding of potential differences in drug efficacy and tolerability among diverse populations. 9 These issues highlight the need for evidencebased interventions to improve participation of Latino patients in clinical research. 13,14,21,22 BARRIERS TO PARTICIPATION Barriers to participation in CTs, biospecimen research, and biobanking are complex, multilevel, and multifactorial, including study design (eg, protocol length and complexity, patient exclusion criteria, trial duration, and high frequency of office visits), health care system barriers (eg, lack of minority staff), patient-related factors (lack of awareness, low health literacy, language, and social determinants of health [SDoH]), and medical team issues (eg, lack of cultural competence, lack of referrals, implicit bias, and provider/patient communication).…”