Trial Participation and Inclusion
Goldie S. Byrd, Rosalyn Lang, Sharon W. Cook, Christopher L. Edwards, and Grace E. Byfield
Significance of Minority Inclusion in Research
The number of studies requiring human subjects has experienced a recent and unprecedented growth. Advocacy from patient groups has created the need for researchers to diversify their clinical and human subjects populations like never before. Given the important role that demographic characteristics play in accounting for unique variance in clinical outcomes, increasingly researchers have been forced to integrate diverse populations guided by the science instead of policy. Ongoing research has become more complex, extensive, invasive, and inclusive of diverse groups across the lifespan. Diversity is increasingly perceived as the strength
G.S. Byrd, Ph.D. (*)
Department of Biology, College of Arts and Sciences, Center for Outreach in Alzheimer’s, Aging and Community Health (COAACH), North Carolina A&T State University,
1601 East Market Street GCB A-411, Greensboro, NC 27411, USA e-mail: This email address is being protected from spam bots, you need Javascript enabled to view it
R. Lang, Ph.D.
Department of Biology, North Carolina A&T State University,
1601 E. Market Street, Greenboro, NC 27411, USA e-mail: This email address is being protected from spam bots, you need Javascript enabled to view it
S. W. Cook, Ph.D., M.S.W.
Department of Sociology and Social Work, North Carolina A&T State University,
1601 East Market Street, Greensboro, NC 27411, USA e-mail: This email address is being protected from spam bots, you need Javascript enabled to view it
C.L. Edwards, Ph.D.
Department of Psychiatry and Behavioral Sciences, Department of Psychology & Neuroscience, and Department of Medicine, Duke University School of Medicine, 932 Morreene Road, Durham, NC 27705, USA
G.E. Byfield, Ph.D.
Department of Biology, North Carolina A&T State University,
1601 E. Market Street, Greensboro, NC 277411, USA
© Springer International Publishing Switzerland 2017 L. Cummings-Vaughn, D.M. Cruz-Oliver (eds.), Ethnogeriatrics, DOI 10.1007/978-3-319-16558-5_6
associated with great research rather than a cumbersome and costly obstacle to good research to be avoided. The acknowledgment that the US population is aging, and the understanding that the aging mind and body are important, have led to a new interest in ascertaining aging samples representing diverse populations into clinical investigations. Although researchers’ interests in aging and other diverse populations have increased, advances in knowledge and technology related to obstacles to effective ascertainment have remained less than optimal. Ensuring that diverse groups and their subgroups are participating in research and clinical trials at significant levels continues to be a challenging but important goal in assuring overall better understanding of disease and health for all populations. Research that serves the needs of all populations can be met when the goal of ecologically valid research— research that can be generalized to real-life settings—is realized in studies that emphasize inclusion and research findings in diverse populations, reduce health disparities, and increase consumption and utilization of research across domains.
Although health disparities remain a disconcerting issue for countries like the United States (US), assuring appropriate and representative sampling in clinical research studies remains one of the most viable health disparities reduction strategies. According to the National Institutes of Health (NIH), health disparities research focuses on studies that seek to understand, treat, or prevent diseases or disorders that are more prevalent in medically underserved communities. While certain diseases and conditions are very much associated with socioeconomics and low levels of formal education, the high prevalence for many is due to the underrepresentation of highly affected and highly marginalized groups in research and clinical trials. Underrepresented groups remain disproportionately high in health disparities and low in research participation. In years 2011 and 2012, African Americans represented 9 and 12.3 % of the total enrollment, respectively, in NIH-Defined Phase III clinical trials. The enrollment percentage for American Indians and Asians was 2.5 % and 1.1 % in 2011 and 2.0 % and 1.2 % in 2012, respectively. Hispanic enrollment in NIH clinical research has been as low as 4.6 % in 2003 and as high as 20 % in 2012. Overall enrollment for Whites was 67 % in 2011 and 62.9 % in 2012. In 2012, total enrollment of minorities in all NIH clinical research was 36.5 %. This equals the percentage recorded for minority enrollment in 2003 (36.5), although the trend fluctuated throughout that time span. Overall minority enrollment in NIH domestic clinical trials showed an increase from 2008 (28.9 %) to 2011 (40.6 %); however, a small decrease in enrollment was seen in 2012 (36.5 %). These data highlight a gap in minority enrollment, especially for minorities that will become the majority of the United States Population in the near future. Close attention and progress are needed to address how investigators will improve research access for underserved minority populations while reducing the burden of health disparities in this country.
