Published: 15th Jun, 2023
Context
The U.S. National Institutes of Health (NIH) Revitalization Act of 1993, mandated the inclusion of “women and minorities” in clinical trials in a bid to reduce health disparities and explore the field of gender-specific research in medicine.
- However, till now there is no such inclusion by many countries across the world.
About
- The National Institutes of Health (NIH) has issued new guidelines to encourage more inclusion of women in clinical studies.
- However, subsequent government analyses found that women were still seriously underrepresented in important studies on common diseases such as heart disease.
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The National Institutes of Health (NIH) is the primary Federal agency for conducting and supporting medical research. Food and Drug Administration (FDA) works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. |
India’s medicine research scenario:
- In India, considered to be the “pharmacy of the world”, the gender disparity in clinical trials has even bigger implications, especially in terms of generic drug production and consumption.
- It has been demonstrated in various studies that women’s bodies respond differently to the components of generic drugs.
- According to the University of Melbourne, Australia, mentioned that inclusion of women in clinical trials for generic medicine, “nearly one-fifth of medications showed a difference in the active dose between men and women”.
Implications of excluding Women from medicinal Trails:
- The exclusion of women from clinical trials and research projects addressing sex-agnostic critical illnesses such as cancer and heart disease has resulted in a limited understanding of sex-specific symptoms and responses to treatment.
- More mortality issues: Women are facing mortality due to poor reproductive health and still world has less widely discussed topic of women’s health.
Women and Health issues in India:
- Health of Adolescent Girls: At the adolescent age 70% of the girls are anaemic and their problems related to their menstrual health and hygiene often go unaddressed.
- Adolescent Fertility Rate (AFR): The United Nations defines Adolescent Fertility Rate (AFR) as the annual number of births to women aged 15-19 years per 1,000 women.
- Among 22 surveyed states as per National Family Health Survey-5, Tripura recorded the highest AFR with 69 births per 1,000 women.
- Teenage Pregnancies: There are 3 times more chances of deaths of girls in teenage pregnancies. Reproductive and sexual health needs of women are often ignored.
- Reproductive Health Issues: 70% of women of India are suffering from reproductive tract infections which may lead to infertility, abortions and similar kind of problems that are perceived as normal.
- Maternal Mortality Rate: Maternal Mortality Ratio (MMR) is defined as the number of maternal deaths during a given time period per 1, 00,000 live births during the same time period.
Suggestive measures:
- The study must be conducted at the level of mortality, serious morbidity, and nutritional status and through proven, evidence-based interventions.
- In this respect, conducting the best quality of research (research that provides firm and ethical evidence adhering to the principles of professionalism, transparency, and auditability) with the use of robust methods is mandatory.
- With the reduced quality of information produced, a lot of money has been wasted; subsequently, the existence of all kinds of bias affects the research itself and jeopardize the validity of the findings and, consequently, the care of women. Thus, this needs to be addressed.
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