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Women Underrepresented in Clinical Trials
by
findingDulcinea Staff
Researchers long assumed that men and women respond similarly to treatments derived from clinical trials. Now they’re finding that’s not always the case.
30-Second Summary
Clinical trials help physicians find better ways to diagnose, treat and prevent disease. They also help compare the effectiveness of one medical treatment against another.
For years, these trials have been performed almost entirely on men. But scientific evidence is now showing that women can be different than men in drug reactions, disease susceptibility and symptoms.
“We talk a lot about personalized medicine, but before you get to true personalized medicine, you have to look at the sex of the person,” said Teresa Woodruff, director of the Institute for Women’s Health Research at Northwestern University.
Researchers are beginning to recognize a need for better representation in clinical trials on a multitude of levels.
In trials testing drug effectiveness, older populations, minorities, rural populations and disabled individuals have been “routinely excluded or under-represented” for years, according to U.S. News & World Report.
Omitting certain demographics can make it hard to know the true effectiveness of a drug. Individual factors like age, race and culture can make a difference in success rates.
Recognizing the need for a more diverse group of clinical trial patients is good, says analyst Armin D. Weinberg. Though the problem, he added, is that this recognition “has yet to have a real impact on studies themselves.”
Ultimately, says Woodruff, better representation must happen because it can save lives.
For years, these trials have been performed almost entirely on men. But scientific evidence is now showing that women can be different than men in drug reactions, disease susceptibility and symptoms.
“We talk a lot about personalized medicine, but before you get to true personalized medicine, you have to look at the sex of the person,” said Teresa Woodruff, director of the Institute for Women’s Health Research at Northwestern University.
Researchers are beginning to recognize a need for better representation in clinical trials on a multitude of levels.
In trials testing drug effectiveness, older populations, minorities, rural populations and disabled individuals have been “routinely excluded or under-represented” for years, according to U.S. News & World Report.
Omitting certain demographics can make it hard to know the true effectiveness of a drug. Individual factors like age, race and culture can make a difference in success rates.
Recognizing the need for a more diverse group of clinical trial patients is good, says analyst Armin D. Weinberg. Though the problem, he added, is that this recognition “has yet to have a real impact on studies themselves.”
Ultimately, says Woodruff, better representation must happen because it can save lives.
Headline Link: Gender differences in disease
Researchers are beginning to recognize the need for “gender-specific thinking” when studying diseases, according to the Chicago Tribune. As a result, some medical institutions have created specialized research centers for learning how men and women differ with regard to health care needs.
Source: Chicago Tribune
Reactions: Addressing the problem of representation
Northwestern University’s Feinberg School of Medicine announced the creation of the Institute for Women’s Health Research in 2006. The organization has dedicated itself to better understanding women’s medical needs.
Source: Institute for Women’s Health Research
Related: Reviewing the clinical trial process
A recent review of the clinical trial process found that not only are women underrepresented in trials, but minorities, elderly populations and other groups are as well. However, Adil Shamoo, a professor of biochemistry and bioethics at the University of Maryland School of Medicine in Baltimore, says finding a diverse trial patient group shouldn’t be hard. “We have an extremely willing volunteer population in this country, so there is no question that proper trial representation is doable.”
Source: U.S. News & World Report
Reference: Clinical Trials
Clinical trials can help researchers find better ways to diagnose, test for or prevent disease. They also help compare the effectiveness of one medical treatment against another. Learn basic information about clinical trials, issues related to clinical trials, and relevant laws and policies at MedlinePlus.
Source: MedlinePlus
ClinicalTrials.gov, a clearinghouse operated by the U.S. National Institutes of Health, provides a list of research clinical trials currently underway to test experimental treatments for many conditions. To learn more about clinical trials, speak to your doctor, and read the U.S. Food and Drug Administration’s guide.
Source: ClinicalTrials.gov
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