Too few women in clinical trials for stroke treatments
Stroke is one of the leading causes of death and researchers say that, without more women represented in clinical trials , our understanding of treatments that work for them is incomplete.
They found women were under-represented in three-quarters of the trials, including those held in Australia."If there are not enough women in these trials and then you make a generalisation that this drug is effective after stroke for preventing another stroke, for example, when clinicians see these trials have not enrolled enough of the population you want, they may not give those medications to women.
"This precludes women from actually getting new therapies," Dr Carcel said.Neurologist Professor Bruce Campbell from the Stroke Foundation agreed it was essential that clinical trials were representative.Especially as they continued to try to answer some of the most challenging questions in stroke treatment, such as how best to open blocked arteries early after a stroke.Read more: ABC News »
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Read more They found women were under-represented in three-quarters of the trials, including those held in Australia. "If there are not enough women in these trials and then you make a generalisation that this drug is effective after stroke for preventing another stroke, for example, when clinicians see these trials have not enrolled enough of the population you want, they may not give those medications to women. "This precludes women from actually getting new therapies," Dr Carcel said. Neurologist Professor Bruce Campbell from the Stroke Foundation agreed it was essential that clinical trials were representative. Especially as they continued to try to answer some of the most challenging questions in stroke treatment, such as how best to open blocked arteries early after a stroke. "Then there's many different ways of potentially improving recovery from stroke," Professor Campbell said. "Obviously, we know stroke is a very disabling condition and anything that can help the brain recover would be incredibly valuable." Women who have a stroke are often older and, if they survive, they can face serious complications. Barriers to entry Professor Campbell does not think women are intentionally under-represented in clinical trials but, he said, there can be barriers. "The nature of the disease is that women are often older when they have their stroke, often don't have a partner at the time and a lot of our stroke trials rely on the partner to consent for the patient to enter the trial." "So, there are some structural issues and facts about stroke that do make it more difficult to recruit women," he said. Dr Carcel agreed that it was not intentional but she pointed out that a stroke treatment trial a few years ago shows why it matters. "When they looked at the results by sex, they found this procedure is protective in men but it did not have results in women. "What they found was it was actually more harmful in terms of adverse events for women. And serious adverse events means either death and hospitalisation," she said. "Including more women in trials is good science." Posted