Inclusion of Women in Clinical Trials Still an Issue
I have written on women being included in clinical trials in 2019. The article I was asked to write included Clinical Trials, reviewing the issues with Essure, and also Maternal Mortality. Three issues which had much detail and information, difficult to cover it all , and could have been much longer. A Woman’s Right to Safe Healthcare Outcomes, Angry Bear.
This article is more recent and includes additional and more up to date detail. The conclusion being (at least to me) there is still issues with Clinical Trials including women. What I have made into an article in a learning module.
Including Women in Clinical Research | Health Inequities, Whitman-Walker Institute’s LGBTQ+, HIV Care and Prevention Training, Eleanor Sarkodie, August 2023
The historical roots of this underrepresentation can be linked back to, among other factors, a general considerations document published by the Federal Drug Administration (FDA) in 1977.
- The consequences of thalidomide use in pregnant women spurred new guidance on excluding women of child-bearing potential from phase 1 and phase 2 research trials. Researchers often assumed women (in this context cisgender women) would have the same response to drugs as men, and viewed them as more complex and expensive participants due to fluctuating hormone levels and reproductive potential.
- The impact of these short-sighted guidelines resulted in decades-long underrepresentation of women in clinical trials research. A study published in 2019 investigated the magnitude of female underrepresentation in clinical studies performed or published between 1966 and 2018. It found that while women made up 49% of all participants enrolled during that time, they were substantially underrepresented in the majority of disease categories examined.
Underrepresentation hindered progress on understanding women’s responses to medications for decades. In 1990, the National Institutes of Health founded the Office of Research on Women’s Health with a mandate to increase women’s participation in research. Finally in 1993, the FDA reversed the 1977 guidance with another guidance that lifted the ban of women of child-bearing potential in early phase research. The decision to include women is now left to researchers, regulatory bodies, and women themselves.
Even so, female underrepresentation in clinical research persisted after the 1993 guidance until 2016. Since early 2016, women represent the majority of participants in clinical trials; male participation has been on the decline since 2017. Women now represent the majority of clinical trial participants in the US, there is still a lack of data distinguishing between cisgender women and women of the transgender experience.
Disparities in clinical trials participation.
Women are especially underrepresented in clinical trials focused on cardiovascular disease, HIV, and hepatitis.
Racial Factors in clinical trials
Not much has changed with including women in medical trials since I wrote on it.
https://english.news.cn/20230705/0bd848d3617b493f84332a0e163780b0/c.html
July 5, 2023
U.S. maternal deaths more than doubled over two decades: JAMA
Among wealthy nations, the United States has the highest rate of maternal mortality.
NEW YORK — Maternal deaths across the United States more than doubled over the course of two decades, and the tragedy unfolded unequally, reported * The Associated Press on Monday, citing a new study ** published in the Journal of the American Medical Association (JAMA).
Black mothers died at the nation’s highest rates, while the largest increases in deaths were found in American Indian and Native Alaskan mothers. And some states — and racial or ethnic groups within them — fared worse than others, the report noted.
Researchers of the study looked at maternal deaths between 1999 and 2019 — but not the pandemic spike — for every state and five racial and ethnic groups.
“It’s a call to action to all of us to understand the root causes — to understand that some of it is about health care and access to health care, but a lot of it is about structural racism and the policies and procedures and things that we have in place that may keep people from being healthy,” Allison Bryant, one of the study’s authors and a senior medical director for health equity at Mass General Brigham, was quoted as saying.
Among wealthy nations, the United States has the highest rate of maternal mortality, which is defined as a death during pregnancy or up to a year afterward. Common causes include excessive bleeding, infection, heart disease, suicide and drug overdose, according to the report.
* https://apnews.com/article/black-maternal-mortality-american-indian-hispanic-deaths-64da18fec80f8f1790aee2e9986a757e
** https://jamanetwork.com/journals/jama/article-abstract/2806661
Maternal mortality in the US is evidently highest among develop nations and has been increasing for some 20 years. Infant mortality is the US is relatively high as well. Life expectancy is relatively low:
https://fred.stlouisfed.org/graph/?g=14GnA
January 15, 2018
Life Expectancy at Birth for United States, Canada, France, Germany, Italy, Japan and United Kingdom, 2017-2021
https://fred.stlouisfed.org/graph/?g=11RG7
January 30, 2018
Infant Mortality Rate for United States, Canada, France, Germany, Italy, Japan and United Kingdom, 2017-2021
Correcting:
Maternal mortality in the US is evidently highest among developed nations and has been increasing for some 20 years. Infant mortality in the US is relatively high as well. Life expectancy is relatively low.
https://fred.stlouisfed.org/graph/?g=15a9v
January 15, 2018
Life Expectancy at Birth for United States, United Kingdom, France, Germany and Italy, 2017-2021
https://fred.stlouisfed.org/graph/?g=15a9P
January 30, 2018
Infant Mortality Rate for United States, United Kingdom, France, Germany and Italy, 2017-2021
“It’s a call to action to all of us to understand the root causes — to understand that some of it is about health care and access to health care, but a lot of it is about structural racism and the policies and procedures and things that we have in place that may keep people from being healthy,” Allison Bryant, one of the study’s authors and a senior medical director for health equity at Mass General Brigham, was quoted as saying.
[ There has just been a PBS program on the legacy of the cotton economy in the South, with a frightening legacy being the serious health problems that run through the cotton belt. The scientist-moderator being shown maps of the cotton belt health effects simply gasps:
https://www.pbs.org/video/how-geology-influenced-cotton-production-ghq4xm/ ]