Abstract
BackgroundWhile women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials.MethodsPatients with CVD (and/or risk factors) and patients with other chronic conditions from Iowa were recruited from a commercial panel. An on-line survey assessed willingness to participate (WTP) and other attitudes towards aspects of clinical research studies.ResultsBased on 504 respondents, there were no differences in WTP in patients with CVD compared to patients with other chronic diseases. Across all respondents, men had 14% lower WTP (relative risk (RR) for men, 0.86, 95% CI, 0.72–1.02). Among patients with CVD, there was no significant difference in WTP between women (RR for women = 1) and men (RR for men, 0.96, 95% CI, 0.82–1.14).There were no significant differences based on sex or CVD status for attitudes on randomization, blinding, side effects, conflict of interest, experimental treatments or willingness to talk to one’s physician. Women had more favorable attitudes about participants being treated like “guinea pigs” (RR for men, 0.84, 95% CI, 0.73–0.98) and clinical trials being associated with terminally ill patients (RR for men, 0.93, 95% CI, 0.86–1.00).ConclusionsThe findings reported here suggest that the observed lower levels of participation by women are due to factors other than a lower WTP or to women having more negative attitudes towards aspects of study participation. Patients with CVD have similar attitudes and WTP as patients with other chronic conditions.
Highlights
While women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials
We found no significant differences between men and women regarding their attitudes towards randomization, blinding, side effects, conflicts of interest or the association of Clinical research studies/clinical trials (CRS/CT) with experimental treatments
Our study of attitudes towards CRS/CTs among Iowans with chronic conditions shows no significant differences in willingness to participate (WTP) for women or people with CVD
Summary
While women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials. Cardiovascular disease (hereafter, CVD) is the leading cause of death for women in the United States [1]. Clinical research has identified important sex-related differences with respect to CVD diagnosis, treatment and outcomes [6]. Most studies documenting the under-representation of women in clinical research on CVD focus on behavior, i.e., enrollment [11,12,13,14,15,16]. Research on clinical trials for other conditions (e.g., cancer) suggests that patient attitudes are an important determinant of participation. A national survey [17] found that 45% of respondents felt that cancer patients participating in clinical trials were “treated like ‘guinea pigs’.”. A national survey [17] found that 45% of respondents felt that cancer patients participating in clinical trials were “treated like ‘guinea pigs’.” On the other hand, a sample of outpatients collected in a Midwest hospital found a high proportion (68%) interested in participating in a clinical trial [18]
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