R.They say that the first step admits that you have a problem, and in the forefront, the UK’s Medicines and Healthcare Organizational Agency (MHRA) has made some progress that affects the need. The agency, which is responsible for approval of all clinical trials in the United Kingdom, has determined a “remarkable imbalance” in the experiments between 2019 and 2023: there was nearly twice the number of experiments that occur in all trials.
This imbalance is not surprising: I also documented in non -visual women, my writing on the female data gap, and the failure to represent women in clinical experiences represents a long -term and global problem. The MHRA numbers are also in line with a modern American analysis. It was found that the male currency diseases are almost receiving twice Financing As a female disease, both, both and the burden of the disease. To date, a disappointing standard.
However, it is not all bad news. When I originally looked at the scene of the clinical experience in the United Kingdom in 2018, I was shocked when I found that we were too much when it was about to process the data gap in women’s health – not in a good way. Unlike the European Union, the United States, Canada and Australia, the United Kingdom has emerged for its failure to say anything at all on this. There were no financing requirements, no approval requirements. We have not collected any data to track the problem. In this context (not to mention the background of the Trump administration Drag away From evidence-based research), the fact that MHRA-for the first time ever-has performed this research very welcome.
The analysis also found that 90 % of experiments included both sexes, which may be in the face of the most good news. But here is the place that becomes more complicated: the inclusion of both sexes in an experience in any way does not guarantee that researchers will think about any gender differences. and 10 years analysis Experience before clinical in the United States showed that although there was an increase in the number of studies that included both sexes, there was no relative increase in analysis and gender reporting. During, Through a set of specialtiesOnly 5-14 % of studies are taught by sex results, and Less than a third From the results of the third stage, sex experiments are reported in medical magazines.
One of this trialPublished in 2023 in the New England Medicine Journal, Alzheimer’s drug is called Lecanemab. You may have read about this: it was praised through the international press as an escape.The beginning of the end“For Alzheimer’s disease. Indeed, it seemed exciting, not at least because it was the first drug found to reduce the rate of cognitive decline in patients. Yes, the experiment included both sexes, but like The vast majority From Alzheimer’s research, and though Well -noted Sexual differences in Alzheimer’s width and spread, did not do any sexual analysis.
Here is the reason for the importance of this. The research paper said that LECANEMAB reduced the rate of cognitive decrease in patients by 27 %, from which the reasonable reader may be concluded that this effect on all patients. But if you look at sex data (which was only provided in a supplementary index), it seemed as if the drug may have this effect on any patients at all: for men, the average slowdown rate was much higher (43 %), while women were much lower (12 %). If this data is correct, this is clear evidence of the importance of sex analysis for men as much as no muddy person serves numbers.
Unfortunately, since the experiment was not prepared to reveal sexual differences, it is impossible to know whether this contrast is a real influence, so there is no more than a frustrating suggestive warning story (although it is worth noting that A. Subsequent analysis Last month, it was published, which conducted 10,000 simulations using study data, and found that the sexual teams occurred randomly only 12 times). But it is far from an isolated condition. My favorite example is the inability to predict the muscle stem cells, which seems to enhance muscle regeneration on a whim, so that anyone thinks about it. Sex does not exceed data She realized that she was not expected at all, as male and female cells acted differently.
MHRA’s failure to communicate anything about sex analysis in the experiences he studied is a major defect in his research. More importantly, MHRA data actually tells us very little about the representation of women in clinical trials in the United Kingdom at all, because the inclusion of both sexes in the trial is also not a guarantee that both sexes are evenly represented. In fact, usually They are not so.
Cardiovascular diseases, for example, is the first killer of women worldwide. Women are 50 % more likely than men who are diagnosed after a heart attack. We know much less than female risk factors for developing heart disease, and most risky prediction models are still dependent on male data often-and this means that they are Systemically naming Women exposed to low risk because they do not suit the male pattern of the disease. But heart infection experiments are not exclusive male; It is just a representation of women in it “still”LowHow many experiments in the MHRA data group will deserve the same description? We simply do not know.
MHRA analysis is not perfect. Even in the study of sex -based gaps, there were large sex -based gaps left in the dark on decisive data points. Female representation is still in 90 % of Britain’s clinical trials unknown; Meanwhile, gender patients are let down due to the failure to track sex analysis. All this means that from the point of view of the gap in female data, this study was not done well – but, I am still pleased because it was done at all.
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Caroline Credo Perez, author of “Non -Women”: exposing the bias of data in a designed world of men
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