International Journal of Cardiovascular Sciences. 05/Sep/2022;35(5):563-5.
How Diversity, Equity and Inclusion are Changing Clinical Research
Clinical research must be translated into changes in clinical practice. One of the difficulties faced by physicians is how to apply results of randomized clinical trials to patients with different profiles from those enrolled in the studies. So, one common question is: Is it appropriate to use clinical trial results in my patient? It is not easy to make clinical decisions based on results from clinical research that does not consider racial identity, ethnicity, age, or gender of patients. One important initiative in science is to promote diversity, equity and inclusion in clinical research in order to produce more reliable data.
Women are historically underrepresented in cardiovascular disease trials, despite sex-determined differences that lead to different forms of clinical presentation and therapeutic management. In cardiology, clinical presentation, risk stratification, prevention, treatment, and outcome parameters are gender sensitive, and this should be taken into account when designing clinical trials. Recently, the American College of Cardiology’s Cardiovascular Disease in Women Committee Leadership Council pointed out the low rates of women enrollment in cardiovascular research: the rates of women across coronary artery disease, acute coronary syndrome, and heart failure trials were 27.3%, 26.9% and 28,6%, respectively. Sex-specific data concerning therapy is essential because women may respond differently than men and may even have adverse effects from some drugs at the same dosage that are beneficial to men. To being with, part of this small participation of women in cardiovascular (CV) clinical trials can be attributed to the limited diversity in the leadership of these studies: only 10% of members in leadership committees of CV clinical trials are women. A similar number of 10% of CV trials published have a woman on the first or last author position. Women need to be included, respected, empowered, and adequately represented in clinical research to guarantee the applicability of the results to their gender. Recently, the International Journal of Cardiovascular Sciences endorsed SAGER guidelines to improve the reporting of sex and gender in research while creating an environment able to integrate equity of sex and gender into manuscripts as an integral part of the editorial process. , As women, minorities also have been underrepresented in CV clinical studies. Some minority populations have shown disproportionately higher rates of certain diseases such as hypertension, heart failure and cerebrovascular disease.
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