Preclinical research and clinical trials are male-biased. What it means for therapy. (6)
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More medical research is done in males and male-derived tissues and cells. There are studies that in 75% of medical research the sex of cells and tissues is not reported. More males than females enroll into most clinical trials, except for gender-specific diseases. There is some data that only 30 percent of heart disease trials that did include women actually reported results by gender. It’s according to recent analysis. What are we missing by continuing male-biased medical research? How to overcome male-biased research? Again, you keep using that word “gender” incorrectly. I keep correcting you. It is sex differences that you’re talking about. Absolutely, more males are enrolled in clinical trials than females. We have to address the influence of sex on the efficacy of a specific drug. It’s not just a matter of having an equivalent number of males and females in clinical trials. Also you have to appreciate that females might be on a contraceptive. Females may be in different stages of their menstrual cycle. Females may be pre-menopausal or post-menopausal. So in order to have a really good representation of females in a clinical trial, you have to represent all those different factors. Suddenly the numbers of individuals in a clinical trial that will address sex increase. Numbers hasn’t just doubled, it’s gone up exponentially. And the cost of clinical trial has also risen exponentially. So there’s been a hesitancy to address the issue of sex partly because many drugs are as effective in males and in females. The problem happens when a drug goes to market. There is what we call post-marketing surveillance. Very often – perhaps I should not say “very” word. But often one sees that adverse events may be more severe in females than males. It is because side effects of a drug were not addressed by sex in the clinical trial. There are drugs that are taken off the market by virtue of those adverse events in females. So the cost to do a clinical trial with sex difference consideration may be quite significantly larger. But if you have to then withdraw the drug because of adverse events, that’s an incredible waste of time, energy. It obviously costs a lot of money to withdraw a medication from market.
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