Gender Gap in Clinical Trials Is Harming Women’s Health

At the moment, there are various clinical trials for coronavirus taking place in different countries around the world in order to develop a vaccine that is fundamental in ending the ongoing health crisis.

While a number of trials have reported success and positive results, some of the problems in the design of the trials may become a cause of concern for people in the future.

More specifically, one of the issues with setting clinical trials and testing for vaccines, medicines, and other treatments has been the lack of women or the gender gap. This means that the majority of the participants of most of the trials are men and the number of women is usually very low in comparison.

According to studies conducted by researchers from the University of Chicago and the University of California in Berkley, this is also a problem in many of the previous trials and most likely be an issue in the recent coronavirus trials being held across the globe.

The researchers reached this conclusion through an analysis of various treatment approvals, trial results in journals, and previous studies. In addition, they also found that as many as eighty-six of the drugs approved for use by the U.S. Food and Drug Administration were based on trials with a big gender gap in them.

With less female representation in trials, the standard dosage is set by its efficacy tested in men only. Secondly, women may also face distinctive health effects and adverse outcomes that may not occur in men due to the gender gap.

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For instance, the commonly used sleeping-aid Ambien was based on a similar clinical trial which is why many women who used it experienced a number of side effects. Later, the dosage for women was revised to half of what was being prescribed before after further investigation. The drug also prompted the researchers to conduct the recent study and review flaws in clinical trials.

Another finding after reviewing existent research was that women experienced stronger and almost twice the adverse effects in ninety percent of the cases when they were given the dosage prescribed to men.

According to researchers, various factors come into play on how different sexes may respond to medicine including intestinal enzymatic activity, lower body mass index, rate of kidney function, differences in drug elimination time period, and many others.

The professor emeritus of psychology and integrative biology at Berkeley and leading investigator of the study, Irving Zucker, explained women have been largely excluded from clinical trials and testing historically because of the concern of the impact of the drug being tested during pregnancy and because of the belief that different hormones in women make them ‘difficult’ to study.

Today, the representation has improved for women especially in the last and phase III of the clinical trials. However, the initial stages are almost always comprised of a majority of men and a much lower number of women in comparison.

Therefore, there is a need for more female representation and further improvement for the future clinical trials and even the ongoing clinical trials for the coronavirus infection.