Sex Differences in Perceived Risks, Distrust, and Willingness to Participate in Clinical Trials

Ding, Eric L.; Powe, Neil R.; Manson, Jo Ann E.; Sherber, Noëlle S.; Braunstein, Joel B.

doi:10.1001/archinte.167.9.905

Cited by 154 publications

(133 citation statements)

References 56 publications

Supporting

Mentioning

124

Contrasting

Unclassified

Order By: Relevance

“…Previous studies of chronic illness and prevention trials are inconsistent but suggest a possible influence of age, sex, race/ethnicity, and educational level. [11][12][13][14][15][16][17][18][19][20] In our study, we were unable to identify any such factors associated with trial consent. Further, we expected that subjects with more severe strokes would be more inclined to participate in the face of a more dire prognosis, but could not find any relationship between participation and stroke severity.…”

Section: Discussionmentioning

confidence: 70%

Who will participate in acute stroke trials?

Kasner

Giudice²,

Rosenberg³

et al. 2009

Neurology

View full text Add to dashboard Cite

show abstract

Section: Discussionmentioning

confidence: 70%

Who will participate in acute stroke trials?

Kasner

Giudice²,

Rosenberg³

et al. 2009

Neurology

View full text Add to dashboard Cite

show abstract

“…Prior evidence suggests women were 15% less willing to participate in clinical trials as compared to men because of concerns about treatment-related side effects. 28 However, a gender difference in willingness to participate does not fully explain why variation existed between different cardiovascular conditions. Several limitations of this study merit discussion.…”

Section: Discussionmentioning

confidence: 99%

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

et al. 2011

View full text Add to dashboard Cite

Many studies have demonstrated that women are substantially underrepresented in cardiovascular trials, but few have considered that women develop cardiovascular disease at older ages than men. The extent to which observed gender enrollment inequalities persist after accounting for age-gender differences in disease prevalence is unknown. The purpose of the study was to compare observed rates of women participating in cardiovascular clinical trials with expected rates of female participation based on age-and gender-specific population disease prevalence. Publications between 1997 and 2009 in the three leading medical journals were included to calculate observed women's enrollment rates. Population-based data in Canada were used to determine the expected enrollment rates of women. Multicenter, randomized cardiovascular clinical trials that enrolled both men and women were analyzed. Two reviewers independently extracted data on women's enrollment and important clinical trial characteristics. The female enrollment rate was 30% in the included 325 trials, which ranged from 27% in trials of coronary artery disease, 27% in heart failure, 31% in arrhythmia, to 45% in primary prevention. Increased female enrollment correlated strongly with increasing age at recruitment in cardiovascular clinical trials (P< 0.001). After accounting for age-and gender-specific differences in disease prevalence, gaps in female enrollment were much lower than the expected enrollment rates estimated by 5% in coronary artery disease, 13% in heart failure, 9% in arrhythmia, and 3% in primary prevention. Only cardiovascular trials were evaluated in our study. Female underrepresentation in cardiovascular clinical trials is smaller than conventionally believed after accounting for age-and gender-specific population disease prevalence. Our findings suggest that greater representation of women in cardiovascular clinical trials can be achieved through the recruitment of older populations.

show abstract

“…Women may differ from men in their perception of risk from cardiovascular disease and in the risk benefit ratio from the intervention being tested as well as in their risk taking behaviors. 34 An accurate measure of this phenomenon can be obtained by the conduct of robust concurrent funded registries that identify the proportion of women both in the parent trial and in the community at large. Questionnaires that study the attitudes of women, the elderly, and minorities to clinical trial participation should be an integral component of the consent process.…”

Section: Barriers To Enrollment In Cardiovascular Clinical Trialsmentioning

confidence: 99%

Status of Women in Cardiovascular Clinical Trials

Kim

Menon

2009

ATVB

142

View full text Add to dashboard Cite

The Burden of Cardiovascular Disease in WomenCardiovascular disease (CVD) is the most common cause of death in American women and accounts for a full one-third of all deaths. 1 Although the common perception may be that CVD affects mainly men, there is equal prevalence of this disease between the genders by the age of 40, and by the age of 60 more women than men are affected. More women than men have died from CVD causes on a yearly basis since the mid 1980s, and whereas the CVD mortality has steadily declined in men over the past 30 years, it has remained steady in women until very recently when CVD mortality was noted to decrease for both genders. 2 See accompanying article on page 277The impact of cardiovascular disease (CVD) on the health status of American women is gaining more recognition and has become the focus of public education efforts such as the "Go Red for Women" campaign sponsored by the American Heart Association and the "Red Dress" project sponsored by the Department of Health and Human Services, the National Institutes of Health (NIH), and the National Heart Lung and Blood Institute (NHLBI). These programs are, in part, a response to the increasing awareness of cardiovascular disease as a major source of morbidity and mortality in U.S. women. Inclusion of Women in Clinical Trials:A Historical PerspectiveThe importance of CVD as a major source of mortality in women was recognized early on by federally funded institutes including the Public Health Service Task Force, which brought attention to concerns about the health information available to women and the historical lack of research focus on women's health in its 1985 Report of the Public Health Service Task Force on Women's Health Issues. 3 In response to this report, the National Institutes of Health adopted a policy for the inclusion of women in clinical research in 1986, and this policy was published in the NIH guide to Grants and contracts in 1987. Six years later, in response to a U.S. General Accounting Office study documenting "little progress" by the NIH in implementing their inclusion policies, Congress approved the NIH Revitalization Act of 1993 which directed the NIH to establish guidelines for the inclusion of women and minorities in clinical research. 4 The NIH Revitalization Act reinforced existing NIH policies for inclusion of women and minorities and stated that in the case of Phase III clinical trials, the "trial is designed and carried out in a manner sufficient to provide for valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial." 5 While federally-funded clinical trials are under the mandate for inclusion of women set by the NIH Revitalization Act, the majority of drug trials (around 80%) are sponsored by pharmaceutical companies. 6 These trials are ultimately regulated by the Food and Drug Administration (FDA), but unlike the NIH, the FDA does not have a federal mandate for inclusion in clinical trials ...

show abstract

Sex Differences in Perceived Risks, Distrust, and Willingness to Participate in Clinical Trials

Cited by 154 publications

References 56 publications

Who will participate in acute stroke trials?

Who will participate in acute stroke trials?

The Impact of Cardiovascular Disease Prevalence on Women's Enrollment in Landmark Randomized Cardiovascular Trials: A Systematic Review

Status of Women in Cardiovascular Clinical Trials

Contact Info

Product

Resources

About