Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Nov 22:2:205-18.
doi: 10.2147/SAR.S23796. eCollection 2011.

Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials

Affiliations

Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials

Jeffrey E Korte et al. Subst Abuse Rehabil. .

Abstract

Introduction: Historically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants.

Purpose: The examination of gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials.

Methods: Reports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s).

Results: Analysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants.

Conclusion: These results are based on a large sample of patients with substance use disorders recruited from a treatment-seeking population. The findings demonstrate that younger participants are less likely than older adults to be retained in clinical trials.

Keywords: addiction treatment; age; clinical trials; ethnic minorities; gender difference; race; recruitment; retention; substance use disorders.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Associations of gender with the availability of primary outcome measure(s), treatment exposure, and attendance at follow-up visits.a Notes: aLeast-squares means and corresponding 95% confidence intervals by gender, for each of the three participation measures. The indicated P-values reflect the comparison between genders.
Figure 2
Figure 2
Associations of race/ethnicity with the availability of primary outcome measure(s), treatment exposure, and attendance at follow-up visits.a Notes: aLeast-squares means and corresponding 95% confidence intervals by race/ethnicity, for each of the three participation measures. The indicated P-values reflect the comparison between race/ethnicity. Abbreviations: N-H A-A, non-Hispanic African American; Hisp, Hispanic; N-H Wh, non-Hispanic white.
Figure 3
Figure 3
Associations of age group with the availability of primary outcome measures, treatment exposure, and attendance at follow-up visits.a Notes: aLeast-squares means and corresponding 95% confidence intervals by age group, for each of the three participation measures. The indicated P-values reflect the comparison between age groups.

References

    1. Koh HK, Oppenheimer SC, Massin-Short SB, Emmons KM, Geller AC, Viswanath K. Translating research evidence into practice to reduce health disparities: a social determinants approach. Am J Public Health. 2010;100(Suppl 1):S72–S80. - PMC - PubMed
    1. National Institutes of Health (NIH) Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research – October 2001 Bethseda MD: NIH; October92001Available from: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.htmlAccessed August 4, 2010
    1. Durant RW, Davis RB, St George DM, Williams IC, Blumenthal C, Corbie-Smith GM. Participation in research studies: factors associated with failing to meet minority recruitment goals. Ann Epidemiol. 2007;17(8):634–642. - PMC - PubMed
    1. Greenfield SF, Brooks AJ, Gordon SM, et al. Substance abuse treatment entry, retention and outcome in women: A review of the literature. Drug Alcohol Depend. 2007;86(1):1–21. - PMC - PubMed
    1. Sullivan PS, McNaghten D, Begley E, Hutchinson A, Cargill VA. Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. J Natl Med Assoc. 2007;99(3):242–250. - PMC - PubMed

LinkOut - more resources