Gender bias could make your results irrelevant
We’re more than 100 years on from when Emily Davidson threw herself under King George V’s horse in the name of female rights - and yet the healthcare industry, the champions of humanitarian work, continue to lack feminism.
An article by The Guardian, published in July last year, outlined the five major medical biases against women today: heart disease is still considered a “man’s disease.” Alzheimer’s in women is diagnosed later due to faulty, early testing. CPR dummies stigmatize the female form. Endometriosis, a gynecological condition, can take up to 7 years to diagnose. And representation in clinical trials is still skewed toward men. While all are of equal importance, for clinical research recruiters it is absolutely crucial that the latter of these problems is addressed. The ballot box is not the only place where women’s representation should matter.
Why does it matter?
If the Institute of Medicine recognizes the distinct anatomical differences between male and female then all successful pharmaceutical research must do the same. In theory, every clinical study should work their trials to fit the specific requirements of each sex; however, in practice, recent evidence suggests otherwise.
In 2014, a report by the Brigham and Women’s Hospital in Boston concluded that the science that informs medicine – including the prevention, diagnosis, and treatment of disease – routinely fails to consider the crucial impact of sex and gender. This, the report finds, “hampers our ability to identify important differences that could benefit the health of all”. Additionally, 8 drugs that had found unacceptable risks for women were withdrawn by the Food and Drug Administration between 1997 and 2001.
The result of excluding women means more than just restrictions on profit margins or making an “unremarkable” contribution to science. As the owners of those 8 drugs found out, inherent gender bias in clinical trials can be fatal: the validity of a whole study’s findings becomes questionable. And if your trials are found inconclusive then you can kiss goodbye that FDA stamp of approval.
What can you do?
Gender bias thrives in unethical clinical research so you’d think the solution is a simple one: make your study ethical. Yet, research ethics aren’t universally standardised with various scientific institutes endorsing a range of principles. We suggest the Economic and Social Research Council’s ‘Code of Human Ethics’ as a guideline for any clinical trial. So, we’ve summarised the two essential values of clinical research ethics outlined by ESRC’s report that target gender bias, and are sure to get you thinking female:
In the context of clinical studies, this means that research sites have a duty to candidates. Researchers respect the knowledge, insight, experience and expertise of participants and potential participants. Respectful researchers are willing to explain the nature of the clinical research to which participants are being asked to contribute, and to avoid any unfair, prejudiced or discriminatory practice. So, respect as a tool for eliminating gender bias works operates like this: research sites must communicate to all candidates, regardless of sex, in a friendly and unpatronising manner. If this means spending a little more time answering any questions or resolving any issues then this is not a problem for a respectful researcher. Potential patients want to be treated like human beings - not lab rats.
Clinical studies should be designed, reviewed and conducted in a way that ensures its contribution to the development of knowledge and understanding. Research sites must guarantee that the scholarly standards of their clinical trials are of a significant high quality and robustness. Potential risks of harm and clinical protocol for addressing such difficulties must then be in place throughout the trial, and it is here that past failures to think female have caused major issues.
Researchers need to stop considering women as smaller versions of men. Today, drug dosage measurements for women are sometimes too simply calculated primarily on their body mass and weight. Effective, scientifically integrous work must consider the bodily differences between the sexes that encompasses differences in cell structures, hormones, and even brain patterns.
It’s fair to say that we have come on leaps and bounds since the first demonstrations for women’s rights, with women now being able to achieve goals in more than just the home. Despite all this success, women’s participation in clinical trials and medical studies is consistently low. This, as has been proven, is not only detrimental to our knowledge and understanding of the female form, but also to the health of humanity - an inherent bias towards men in pharmaceutical studies increases the chances of unknown risks for one half of the reproductive pair. What we do know is that it’s the responsibility of all clinical research recruiters to consider the biological differences between the sexes in every stage of their operation and, in doing so, help to smash the glass ceiling.
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