Women's inclusion in cardiovascular clinical trials
The women's health movement in the 1970s is where policies on incorporating women in clinical research have their roots. Although the fight for control over their reproductive rights and a change in delivery practises was the main emphasis of the women activists, this effort also aspired to enhance health care for women generally and put an end to sexism in the health system. The Food and Drug Administration (FDA) suggested in 1977 that women of reproductive potential be excluded from Phase I and early Phase II drug studies, which effectively put a stop to this movement. Due to drug-related situations, such as the tragedy brought on by the administration of thalidomide to pregnant women, this policy was formed. The rule had the effect of significantly excluding women from clinical studies. Many agreed with the demand that women be given the freedom to choose whether or not to face the risk of taking part in a clinical trial.
Others understood the value of include women in research trials to advance medical understanding of sex differences. Long-term studies on how behaviour, biology, and societal factors affect women's health were advised in the 1985 report of the Public Health Service Task Force on Women's Health Issues. The National Institutes of Health (NIH) created a policy to promote the participation of women in clinical trials as a response in 1986. However, the Government Accountability Office (GAO) revealed that the policy had been miscommunicated and enforced inconsistently in a report that was published in 1990. The Office of Research on Women's Health was established by NIH in the same year with the goal of advancing women's health research both within and outside of the NIH scientific community.
The study concentrated on methods for postmenopausal women to avoid osteoporosis, breast and colorectal cancer, and heart disease. With the passage of the NIH Revitalization Act of 1993 by Congress, the National Institutes of Health's policy to include women in clinical studies became Federal law in 1993. The FDA reversed its 1977 rules and promoted the inclusion of women in clinical trials by issuing "Guideline for the study and evaluation of gender differences in the clinical evaluation of medicines" that same year. In addition to age and ethnicity, the FDA began enforcing regulatory restrictions on clinical data reporting in 1998. After these legislative reforms, there has been a gradual increase in the number of women participating in clinical trials, but there has also been a rise in awareness of the need for sex-specific guidelines for patients with or at risk for cardiovascular disease. The American Heart Association (AHA) scientific statement from 1997 outlined particulars of risk factor management and the prevalence of cardiovascular disease in women.
This served as the basis for the AHA's 1999 and 2004 publications of the first sex-specific clinical recommendations and guidelines for the prevention of cardiovascular disease in women, respectively. A assessment of the trials on which the 2007 update of these guidelines was based found that only 30.6% of the 801,198 total patients were enrolled in the 156 trials. Furthermore, findings for women were only expressly reported in one-third of the trials. Strong sex-specific recommendations required immediate improvement with more data on women and a rise in the proportion of women in clinical trials. Despite these requirements, a recent analysis on sex-specific data-reporting, which included 34 randomised controlled cardiovascular drug trials presented at significant conferences in 2017, found that only 23.5% and 8.6% of sex-specific efficacy endpoints and safety outcomes were reported within two years of the presentation, respectively. It's significant that even after accounting for the proportion of women in the population with the relevant condition, the underrepresentation of women is still noticeable. On the other hand, there have been improvements in recent years in the proportion of women participating in trials for heart failure and stroke, compared to the frequency of the diseases. Additionally, it was discovered that women were overrepresented in trials for pulmonary hypertension and underrepresented in trials for hypertension.
Other factors, in addition to the rules that contributed to the low inclusion of women in clinical trials, have also played a role. When women than males present with coronary artery disease, they are often older and have more comorbidities. Women also frequently undergo less invasive treatment, which may prevent them from taking part in trials of percutaneous coronary intervention interestingly. The lower enrollment of women was not due primarily to sex-biased study entry criteria, according to the screening statistics that were available. Pre-screening factors may also be important and make it less probable for women to consider or be considered for trial participation. Regarding the latter, research indicates that women are less likely than males to agree to take part in a clinical trial. A study on 783 participants from 13 clinical facilities in the United States looked at sex differences in perceived risks and mistrust as well as the willingness of men and women to engage in cardiovascular preventive trials. Even after controlling for gender variations in distrust of medical researchers and projected 10-year risk of myocardial infarction, women were considerably less likely to engage than men.
However, adjusting for variations in the perceived likelihood of experiencing damage and benefits totally eliminated sex differences in willingness to engage. Aside from the increased perceived risk connected with trial participation, it has been demonstrated that some women may be concerned about trial participation being a burden on their health and time. Concerning the latter, a study gathered reasons for not taking part in a clinical trial and documented care obligations indicated by women but not by men. These and other considerations must be noted and taken into account in future efforts to enhance women's participation in cardiovascular disease and other trials.
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Martin Joy