TY - JOUR
T1 - Factors associated with enrollment of African Americans into a clinical trial
T2 - Results from the African American study of kidney disease and hypertension
AU - Gadegbeku, Crystal A.
AU - Stillman, Phyllis Kreger
AU - Huffman, Mark D.
AU - Jackson, James S.
AU - Kusek, John W.
AU - Jamerson, Kenneth A.
N1 - Funding Information:
Supported by cooperative agreements U01 DK48682 (University of Michigan), DK45381 (Case Western Reserve), DK48659 (Medical University of South Carolina), DK65473 (Meharry Medical College), DK48669 (University of Alabama, Birminghan), DK48645 (University of California, San Diego), DK45386 (University of Texas, Southwestern) from the National Institute of Diabetes and Digestive and Kidney Diseases. Additional support is provided by the National Center for Minority Health and Health Disparities and the Office of Behavioral and Social Sciences Research, National Institutes of Health.
PY - 2008/11
Y1 - 2008/11
N2 - Recruitment of diverse populations into clinical trials remains challenging but is needed to fully understand disease processes and benefit the general public. Greater knowledge of key factors among ethnic and racial minority populations associated with the decision to participate in clinical research studies may facilitate recruitment and enhance the generalizibility of study results. Therefore, during the recruitment phase of the African American Study of Kidney Disease and Hypertension (AASK) trial, we conducted a telephone survey, using validated questions, to explore potential facilitators and barriers of research participation among eligible candidates residing in seven U.S. locations. Survey responses included a range of characteristics and perceptions among participants and non-participants and were compared using bivariate and step-wise logistic regression analyses. One-hundred forty-one respondents in the one-hundred forty (70 trial participants and 71 non-participants) completed the survey. Trial participants and non-participants were similar in multiple demographic characteristics and shared similar views on discrimination, physician mistrust, and research integrity. Key group differences were related to their perceptions of the impact of their research participation. Participants associated enrollment with personal and societal health benefits, while non-participants were influenced by the health risks. In a step-wise linear regression analysis, the most powerful significant positive predictors of participation were acknowledgement of health status as important in the enrollment decision (OR = 4.54, p = 0.006), employment (OR = 3.12, p = 0.05) and healthcare satisfaction (OR = 2.12, p < 0.01). Racially-based mistrust did not emerge as a negative predictor and subjects' decisions were not influenced by the race of the research staff. In conclusion, these results suggest that health-related factors, and not psychosocial perceptions, have predominant influence on research participation among African Americans.
AB - Recruitment of diverse populations into clinical trials remains challenging but is needed to fully understand disease processes and benefit the general public. Greater knowledge of key factors among ethnic and racial minority populations associated with the decision to participate in clinical research studies may facilitate recruitment and enhance the generalizibility of study results. Therefore, during the recruitment phase of the African American Study of Kidney Disease and Hypertension (AASK) trial, we conducted a telephone survey, using validated questions, to explore potential facilitators and barriers of research participation among eligible candidates residing in seven U.S. locations. Survey responses included a range of characteristics and perceptions among participants and non-participants and were compared using bivariate and step-wise logistic regression analyses. One-hundred forty-one respondents in the one-hundred forty (70 trial participants and 71 non-participants) completed the survey. Trial participants and non-participants were similar in multiple demographic characteristics and shared similar views on discrimination, physician mistrust, and research integrity. Key group differences were related to their perceptions of the impact of their research participation. Participants associated enrollment with personal and societal health benefits, while non-participants were influenced by the health risks. In a step-wise linear regression analysis, the most powerful significant positive predictors of participation were acknowledgement of health status as important in the enrollment decision (OR = 4.54, p = 0.006), employment (OR = 3.12, p = 0.05) and healthcare satisfaction (OR = 2.12, p < 0.01). Racially-based mistrust did not emerge as a negative predictor and subjects' decisions were not influenced by the race of the research staff. In conclusion, these results suggest that health-related factors, and not psychosocial perceptions, have predominant influence on research participation among African Americans.
KW - African Americans
KW - Clinical trials
KW - Subject recruitment
KW - Willingness to participate
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U2 - 10.1016/j.cct.2008.06.001
DO - 10.1016/j.cct.2008.06.001
M3 - Article
C2 - 18639652
AN - SCOPUS:53649100532
SN - 1551-7144
VL - 29
SP - 837
EP - 842
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 6
ER -
