Clinical Trials for Women

It seems as though every day we hear about the results of a new "study" in the media.  But did you ever wonder, "Who are all these patients in these clinical trials?"  Did you ever wonder if you could-or should-be in a clinical trial?  Consider these facts: 

• In the year 2,000 alone, $26 billion was invested in discovering and developing new medicines
• We have heard reports about some pharmaceutical companies having "weak" drug development "pipelines".  Yet surveys for 2000-2001 indicate that there are more than 2,100 new therapies in various stages of development.
• During the next five years, a 10% annual increase in new molecular entities is anticipated.
• Just to complete the 50,000 phase I-IV protocols that are already on-going, another 800,000 patients will be needed.
• It is estimated that there are 50 million eligible study volunteers in the United States, but that only 4 to 5 million people participate in clinical trials annually.
• According to a Harris Interactive survey (spring 2000), 8 out of 10 cancer patients were unaware that clinical trials could be an option for them.  Of those patients who were unaware, 3 out of 4 said that they would have been "somewhat" or "very" receptive had they known about clinical trials.

How does this information match up with all the stories we've heard over the past several years about how women are not being included in clinical trials?  The publication of a report by the U.S. federal General Accounting Office (GAO) in 1989, showing that women were significantly underrepresented in federally sponsored biomedical research, launched a grassroots revolution in women's health research and advocacy that has continued to grow over the past 10 years.  Led by groups such as the Society for Women's Health Research, this movement has already stimulated dramatic improvements-not only in women's health research, but also in women's daily lives. 

We have medicines available now that were only dreams a decade ago - medicines that can lower the incidence of breast cancer in high-risk women and improve survival rates in women who have the disease; ease the symptoms of Alzheimer's disease; slow the progression of multiple sclerosis; improve quality of life for diabetes patients; reduce pain and disability for arthritis patients; and treat or reduce the risk of osteoporosis.  Because women are more likely to be affected by these conditions and because women live nearly 7 years longer than men, the majority of patients taking these medicines are women. And because women are now recognized to have different needs, different responses to diseases, and different responses to medicines, biomedical researchers from the pharmaceutical industry, academia, and the National Institutes of Health (NIH) are continuing to investigate medicines for prevention and treatment specifically in women.

What's new is not just that this research is being conducted, but how it's being conducted.  Researchers are approaching conditions common to both sexes using a newly defined approach called "gender-based research."  This approach involves studying both the similarities and differences in men and women with respect to the mechanism of a disease; potential differences in reactions to preventive and therapeutic measures; how diagnoses may differ; and how this condition and/or its treatments may further react with concomitant conditions, other medicines, and hormones (especially birth control pills and hormone replacement therapy).  Because of the focus on sex-specific research (how drugs or diseases may affect people differently based upon their sex), we also have learned more about medicines that should not be given to women, may not be as effective in women, or may act differently in women.  We have even learned about how various medicines may interact with different female hormones-estrogen and progesterone-when they are endogenous (produced by the body) or exogenous (taken as a medicine as in hormone replacement therapy or birth control pills).