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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | E26-E50 |
| Journal | American journal of respiratory and critical care medicine |
| Volume | 204 |
| Issue number | 3 |
| DOIs | |
| State | Published - Aug 1 2021 |
Keywords
- Clinical research
- Health disparities
- Minorities
- Recruitment
- Retention
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Critical Care and Intensive Care Medicine
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Enhancing recruitment and retention of minority populations for clinical research in pulmonary, critical care, and sleep medicine an official american thoracic society research statement. / Thakur, Neeta; Holguin, Fernando; Alvidrez, Jennifer et al.
In: American journal of respiratory and critical care medicine, Vol. 204, No. 3, 01.08.2021, p. E26-E50.Research output: Contribution to journal › Review article › peer-review
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TY - JOUR
T1 - Enhancing recruitment and retention of minority populations for clinical research in pulmonary, critical care, and sleep medicine an official american thoracic society research statement
AU - Thakur, Neeta
AU - Holguin, Fernando
AU - Alvidrez, Jennifer
AU - Abdulai, Raolat
AU - Appell, Donna
AU - Araojo, Richardae
AU - Bime, Christian
AU - Burchard, Esteban G.
AU - Castro, Lauren
AU - Celedon, Juan C.
AU - Ferreira, Juliana
AU - Ford, Marvella E.
AU - George, Maureen
AU - Graham, Leroy
AU - Hendrickson, Carolyn
AU - Kiley, James P.
AU - Lovinsky-Desir, Stephanie
AU - Mageto, Yolanda
AU - Mainous, Arch G.
AU - Pakhale, Smita
AU - Reese, Rodney
AU - Riekert, Kristin A.
AU - Roman, Jesse
AU - Ruvalcaba, Elizabeth
AU - Sharma, Sunil
AU - Shete, Priya
AU - Spitzer, Ginger
AU - Wisnivesky, Juan P.
N1 - Funding Information: In the United States, the NIH is a major source of funding and, consequently, is a driver of respiratory research in all groups, including minority populations. In response to the 1985 report from the Secretary’s Task Force on Black and Minority Health, the NIH recommended the “expansion of biomedical and behavioral research to assure appropriate emphasis on health problems that disproportionately affect U.S. racial/ethnic minority populations” (134). The need for attention to study-design and sample-size concerns when including minority groups was also emphasized. The NIH Revitalization Act of 1993 further expanded recommendations, requiring all NIH-supported human-subject research to include women and members of minority populations and subpopulations and requiring the NIH to regularly report aggregate data on the inclusion of women and minorities across human-subject research to Congress (135). The NIMHD—established by thepassage of the Minority Health and Health Disparities Research and Education Act of 2000, Public Law 106-525, as the National Center for Minority Health and Health Disparities and later redesignated as the NIMHD with the passing of the Patient Protection and Affordable Care Act in 2010— has been instrumental in spearheading initiativesforguidingtheroleoftheNIH(136). To date, policy changes have had suboptimal impact on minority participation in research. In response, the 21st Century Cures Act of 2016 updated the NIH policy and now requires NIH-defined phase III clinical trials to include valid analyses by sex/gender and race/ethnicity in the results reported in clinicaltrials.gov (137). Implementation and enforcement of this policy is expected to occur at multiple points, including at the time of the grant application and during the review process, as well as when research is funded and ongoing. On a regular basis, the advisory council/board for each of the NIH institutes, centers, and offices (ICOs) are to review compiled inclusion data for funded human-subject research to ensure compliance with this policy. The impact of this new policy is to be determined. Furthermore, the policy falls short; compliance with population composition does not ensure the ability to perform meaningful subgroup analysis for the majority of smaller-sized clinical trials. In addition, this policy for the inclusion of valid subanalyses does not extend to other types of clinical research, including device trials, trials at other stages of the FDA process, or observational research. Another concern is that the strategies implemented by the NIH to enforce this policy vary across NIH ICOs. Efforts should be made to standardized strategies across NIH ICOs and include processes through which to informandtrainscientificreviewofficers(who oversee study section reviews) and program officers (who work closely with investigators after an award is made). A laudable step forward is that since May of 2019, annual data on the inclusion of women and minorities by research, condition, and disease categories in NIH-funded research may be found in the NIH research, condition, and disease category inclusion statistics report (138). Making these data publicly available provides a measurable parameter on which to measure the influence of the Cures Act of 2016 and other efforts to increase minority participation in research. A further step would be to have the data stratified by studies that are minority focused and by those that aim to recruit the general public. Increased transparency will provide guidance on where future efforts should be placed (e.g., more funding/special announcements to support minority-focused studies vs. efforts to improve minority recruitment in general). The NIH has engaged thought leaders and sponsored workshops to identify barriers for the training of a diverse workforce. Several studies have demonstrated that minority investigators are less likely to obtain R01 funding than their White counterparts (139–142). This has important implications, as diversity study team improves minority recruitment and retention. A 2005 effort highlighted several barriers to NIH funding for minority investigators (143): inadequate research infrastructure, training, and development for minority scientists as independent researchers; inadequate mentoring; insensitivity, misperceptions, and miscommunicationaboutthespecificneedsof investigators involved in research with minority communities; institutional bias in NIH policies; unfair, competitive environments; lack of institutional support; limited attention to topics/methods relevant to research with minority communities; and social, cultural, and environmental barriers. Since these pivotal publications (139, 143), the funding gap for early-career awards through the K mechanism has narrowed significantly for minority investigators. Funding for R01 grants to Black and Hispanic/Latinx applicants increased by 8.4% and 10.9%, respectively, from 2013 to 2018. However, we also saw an increase (9.6%) in funding for non-Hispanic White applicants over this time period; thus, the 10% and 4% funding gaps persist for Black and Hispanic/Latinx applicants, respectively (144). Despite more than a decade having passed, more recent assessments identified barriers similar to those highlighted in 2005. To move forward more effectively, Duncan and colleagues (145) recommended a multipronged approach “to enable the professional development and retention of underrepresented minorities in biomedical research, including addressing individual and social factors and [involving] funding agencies, academic institutions, mentoring teams, professional societies, and peer collaboration.” The NIH has engaged in purposeful efforts to address deficiencies in the recruitment and retention of minorities in clinical research, as well as in developing a diverse workforce. This includes the recent release of dedicated funding for research on health disparities and/or upstream factors contributing to racial/ethnic disparities (e.g., BUILD [Building Infrastructure Leading to Diversity] [146], FIRST [Faculty Institutional Recruitment for Sustainable Transformation] Cohort [147], DECIPHeR [Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk] [148], NOT-MD-21-008 [149], and NOT-MD-21-016 [150]) However, the full impact of this funding will not be evident for years to come and may not close the observed gaps. Continuing evaluation of the status, implementation of innovative incentives for minority recruitment and retention in clinical trials, and long-term investment in the development of a diverse research community will require continued advocacy, a reprioritization of resources and funding, and a recognition that the goal of equity in respiratory health is unreachable without everyone’s participation—within and outside of the NIH. To accelerate progress, we provide additional recommendations that would more immediately improve the inclusion of minorities in clinical research: Funding Information: Score or raise the importance of the Inclusion of Women and Minorities section of the NIH grant application. Invest in resources to support recruitment of minority populations (e.g., adding supplements to awards to expand recruitment efforts to include minority populations or to further support awards that already focus on minority populations). Revise criteria in funding announcements to emphasize that recruitment should include racial/ ethnic minorities, particularly for diseases that disproportionately affect these populations. Ensure that scientific review officers receive training to recognize bias in the study section and provide regular instruction to reviewers to reduce bias. Ensure that clinical research, particularly research on diseases affecting minority populations, is adequately funded when awarded and is sufficiency powered to address differences among underrepresented minority groups. Increase the availability of loan repayment programs or other policies that directly or indirectly remove the financial burden of pursuing clinical research endeavors for Black, Latinx, and indigenous trainees and early-career faculty. Publisher Copyright: Copyright © 2021 by the American Thoracic Society.
PY - 2021/8/1
Y1 - 2021/8/1
N2 - 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.
AB - 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.
KW - Clinical research
KW - Health disparities
KW - Minorities
KW - Recruitment
KW - Retention
UR - http://www.scopus.com/inward/record.url?scp=85112234813&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85112234813&partnerID=8YFLogxK
U2 - 10.1164/rccm.202105-1210ST
DO - 10.1164/rccm.202105-1210ST
M3 - Review article
C2 - 34347574
AN - SCOPUS:85112234813
VL - 204
SP - E26-E50
JO - American Review of Respiratory Disease
JF - American Review of Respiratory Disease
SN - 1073-449X
IS - 3
ER -