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Clinical Trials Lack Female Participation

May 23, 2008 | Parker Waichman LLP

Fifteen years ago a ban was lifted limiting female participation in clinical trials.  Regardless, women remain under-represented in research despite evidence that many conditions—such as lung cancer and depression—have gender-based differences.  Only nine percent of female respondents in a survey of 2,000 American adults released this week for “Sex Differences in Health Awareness Day” had participated in medical research; 93 percent said their doctor had never mentioned the opportunity and 25 percent were unaware healthy individuals could participate in such research.

Now, doctors have lack of study participants, which may be problematic for women when developing gender-based treatments, such as when studying a treatment’s interaction with estrogen in a lung cancer tumor.  "As research advanced, we started to recognize more and more that women were not just small men with different plumbing and a hormone problem, that there were real biological differences between men and women that had an impact on whether or not a drug was going to work well or cause side effects," said Sherry Marts, vice-president of scientific affairs at the Society for Women’s Health Research, a group that increases awareness of the need for women to be properly represented in medical research.

Before 1993, women were not permitted to participate in most major medical studies unless they were post-menopausal or had had a hysterectomy, over concern with experimental drugs on future children.  "Here, these companies were putting these drugs on the market and they had never been tested in women but they were being prescribed to women," Marts said.  The Society for Women's Health Research, which commissioned the survey, worked to change that rule and open clinical trials to female participants; the change also forced inclusion of more minorities in trials.

It's important trials include more females and sex-based analysis of results and to break data out by gender to see how men and women may be affected differently, Marts said.  Also, minority women show that there is more than one variable to consider in research, Marts noted, adding that it’s challenging to create a trial with enough participants to conduct large-scale analysis of multiple variables.  Researchers need to figure out which variables are the most relevant and how to design studies that examine those variables.

Other drug trial problems have recently made the news, as well.  For instance the pressure researchers are experiencing from pharmaceutical companies to end drug trials early, which may benefit patients in need of such medications, but could also exaggerate a drug’s benefits.  Critics wonder if drugs are being released to market too soon and if—instead of relying on ultimate outcomes—many studies measure a drug’s effectiveness by using interim markers.

And, then there is the emerging research over problems with the method and processes in which drug trials are conducted in children and indications that more and stricter monitoring is required to ensure the children’s safety.  In a study of 739 trials, two percent had any type of independent safety monitoring committees.

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