Factors Associated With Participation in Clinical Trials Among Patients With Lupus.
Journal
Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases
ISSN: 1536-7355
Titre abrégé: J Clin Rheumatol
Pays: United States
ID NLM: 9518034
Informations de publication
Date de publication:
01 Apr 2022
01 Apr 2022
Historique:
pubmed:
25
1
2022
medline:
29
3
2022
entrez:
24
1
2022
Statut:
ppublish
Résumé
Participation rates for clinical trials, including lupus trials, in the United States are low, but are even lower for underrepresented minorities. The impact of underrepresentation in trials can be far-reaching and is problematic because female subjects of color with lupus experience greater morbidity and mortality. As such, the overarching goal of this study was to characterize the factors that influence participation in lupus clinical trials. The Lupus and Allied Diseases Association, the Lupus Foundation of America, and the Lupus Research Alliance collected data for their externally led Patient-Focused Drug Development Initiative-for the purpose of understanding and improving the rates of participation in lupus-related clinical trials. Participants completed a 46-question survey (in English or Spanish) electronically or on paper, which was distributed online or at lupus events. Logistic regression was used to test whether demographic and disease characteristics were associated with participation in past lupus trials. Data were available for 2220 respondents. Black respondents with lupus were more likely, than their White and Hispanic counterparts, to have participated in past clinical trials (p < 0.05). Although not statistically significant, Hispanic respondents were also more likely to have participated than their White counterparts (odds ratio, 1.40; 95% confidence interval, 0.96-2.11). Both demographic (ie, race/ethnicity) and medical (ie, disease severity defined as more organ involvement) factors seem to be important determinants of participation in clinical trials (p < 0.05). Combining the results from this study and prior research provides insight into recruitment strategies to increase participation rates of historically underrepresented minorities.
Sections du résumé
BACKGROUND/OBJECTIVE
OBJECTIVE
Participation rates for clinical trials, including lupus trials, in the United States are low, but are even lower for underrepresented minorities. The impact of underrepresentation in trials can be far-reaching and is problematic because female subjects of color with lupus experience greater morbidity and mortality. As such, the overarching goal of this study was to characterize the factors that influence participation in lupus clinical trials.
METHODS
METHODS
The Lupus and Allied Diseases Association, the Lupus Foundation of America, and the Lupus Research Alliance collected data for their externally led Patient-Focused Drug Development Initiative-for the purpose of understanding and improving the rates of participation in lupus-related clinical trials. Participants completed a 46-question survey (in English or Spanish) electronically or on paper, which was distributed online or at lupus events. Logistic regression was used to test whether demographic and disease characteristics were associated with participation in past lupus trials.
RESULTS
RESULTS
Data were available for 2220 respondents. Black respondents with lupus were more likely, than their White and Hispanic counterparts, to have participated in past clinical trials (p < 0.05). Although not statistically significant, Hispanic respondents were also more likely to have participated than their White counterparts (odds ratio, 1.40; 95% confidence interval, 0.96-2.11). Both demographic (ie, race/ethnicity) and medical (ie, disease severity defined as more organ involvement) factors seem to be important determinants of participation in clinical trials (p < 0.05).
CONCLUSIONS
CONCLUSIONS
Combining the results from this study and prior research provides insight into recruitment strategies to increase participation rates of historically underrepresented minorities.
Identifiants
pubmed: 35067507
doi: 10.1097/RHU.0000000000001821
pii: 00124743-202204000-00004
pmc: PMC9044505
mid: NIHMS1794047
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
132-136Subventions
Organisme : NCATS NIH HHS
ID : KL2 TR001421
Pays : United States
Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
Conflicts of interest and sources of funding: The authors have no conflicts of interest to report. This research was supported by a Lupus Research Alliance Small Grant to the first author (award number 69300).
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