Health
Research finds women and minorities lack new cardiovascular drug research and clinical trials
of New research It was published in the Journal of the American Heart Association, an open access journal of the American Heart Association.
Cardiovascular and cardiometabolic disorders (a combination of both cardiovascular and metabolic disorders) are the leading causes of death worldwide, and type 2 diabetes Cardiovascular disease About 4 times that of women. Lack of gender and racial diversity in clinical trials evaluating the safety and efficacy of drug therapies for cardiovascular and cardiometabolic disorders is a concern for researchers. In 1993, the US Food and Drug Administration (FDA) established guidelines to increase the diversity of participants in clinical trials.
In this study, the researchers investigated ten-year participation trends among women and racial and ethnic groups in key trials in support of approval of new cardiometabolic drugs. Researchers examined gender and race / ethnic enrollment data from approximately 300,000 trial participants to assess the proportion of women and minorities. On average, about 6,000 people participated in each medication trial. The FDA approved 35 new drugs during the study period (24 cardiovascular and 11 diabetes drugs between 2008 and 2017).
“Demographic characteristics such as race and gender can have a contrasting effect on medication response, which can erroneously lead to variability in treatment outcomes and survival,” said the resident. Said one Dr. Muhammad Shahzeb Khan. Internal medicine John H. Stroger Jr., Cook County Hospital, Chicago. “It is important that the individuals participating in these trials be representative of patients who are clinically treated with these drugs.”
“Unfortunately, we found that women and racial minority registrations remained disproportionately low,” Khan added. “Gender, racial, and ethnic disparities in participants in major clinical trials may have important implications in determining the efficacy of these treatments in these groups, and they may not be relevant to routine clinical practice. It can undermine the generalization of test results. ”
Analysis showed that the proportion of women and minorities in clinical trials for FDA approval remained low over time. From 2008 to 2017, the researchers
-Women accounted for only 36% of study participants.
-Only 4% of study participants were black / African American; -Only 12% of study participants were Asian; and only 11% of study participants were Hispanic / Latin American.
In addition, studies in coronary heart disease, heart failure, and acute coronary syndrome found that the number of women was underestimated compared to the proportion of women with these diseases. The findings strengthen the need to increase the representation of all demographic subgroups to ensure that variability in both benefit and safety outcomes is reported. This information is important so that treatment can be adjusted.
“We investigated women and minority representatives in trials targeting cardiovascular metabolism, but the same principles apply to ongoing trials of Covid-19 therapy. Which drugs work and all We need to know if it’s safe in the demographic subgroup. ”
“Therefore, all therapies currently being investigated as potential treatment options for novels are Coronavirus All demographic subgroups should be equally surveyed so that differences in safety and efficacy can be explained in advance. Inclusion of diverse participants is essential for an overall understanding of gender and race differences in treatment response. ”
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