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
- 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
- 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
- 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).
Because women are now recognized to have different needs, different responses to diseases, and different responses to medicines, biomedical researchers ... are continuing to investigate medicines for prevention and treatment specifically in women.