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Phyllis E. Greenberger, MSW, is the first President and CEO of the Society for Women's Health Research, a Washington, DC-based advocacy organization formed in 1990 to improve the health of women through research. The Society's work has increased awareness of women's health research issues, including the need for research on sex differences. The innovative programs developed under her leadership include the first national conference that examined environmental determinants of women's health; the first conference focused on sex-based biology, the field of scientific inquiry committed to identifying the biological and physiological differences between men and women; and a nationwide health promotion and disease prevention program for young women. Greenberger was also the driving force behind the recent Institute of Medicine report, "Exploring the Biological Contributions to Human Health: Does Sex Matter?" which called on researchers to understand the implications of basic biological sex differences for the betterment of human health.

Clinical Trials: Answering Questions and Saving Lives

Digital mammography, bone marrow transplants, and medications to help control pain, depression, and heart disease are all medical advances that are easy to take for granted.  These advances have been made possible because of medical research, which has given us the knowledge and technology to help women live longer and healthier.  If we are to find cures for cancer, heart disease and AIDS, we will need to continuously expand medical research.  Critical to this expansion are adequate numbers of men and women willing to participate in clinical trials to find new treatments for disease.

However, researchers are finding it more and more difficult to recruit participants for their studies.  Alarming headlines such as "Clinical Trial Center Closed for Ethics Violations," and "Drug Test Halted After a Number of Patients Die," have appeared on the front pages of newspapers and magazines across the country.  Some of the stories of medical research gone badly are disturbing enough to question why you or I should volunteer for a medical research study.  The answer is simple: to advance medical science and save lives. 

Lack of awareness is an even greater impediment to participation in clinical trials.  A recent Harris Interactive survey found that 85 percent of cancer patients surveyed were unaware or unsure that participation in a clinical trial was even an option.  Of the patients who were aware of the option, three out of four turned it down for reasons that included fear of being treated like a guinea pig, fear that they might get a placebo, or that medical care received in a trial would be less effective than standard care.[1]

Yet these fears are generally unfounded.  The same Harris poll of cancer patients who did participate in a trial found that the vast majority of participants felt that they were treated with dignity and respect, received excellent or good care, and had rated their overall experience as being good.  Importantly, most did not feel like they were being treated as a guinea pig.  Newly reorganized offices at the Food and Drug Administration (FDA) and National Institutes of Health (NIH) are instituting safeguards to ensure the safety of volunteers. 

To address the issue of awareness and knowledge of clinical trials, the Society for Women's Health Research instituted the "Some Things Only A Woman Can Do" campaign to provide women with the information and tools they need to make an educated decision about participating in medical research. The Society for Women's Health Research is the nation's only not-for-profit organization whose sole mission is to improve the health of women through research.  Founded in 1990, the Society brought to national attention the problem of the exclusion of women from major medical research studies and the resulting need for more information about conditions affecting women.  The Society advocates increased funding for research on women's health, encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of women in medical research studies.

Countless differences between men and women in health have been identified by researchers in recent years - in heart disease, autoimmune disease, cancer and other areas - and there are many other diseases and conditions to investigate.  These differences haven't been the focus of research in the past because it was assumed that what worked for men worked for women. It is crucial now that research focus on the unique health profiles of both sexes, and that we learn as much as we can about women's health to catch up.

Women of all races, ethnic groups, and economic groups are needed to participate in medical research studies. Including all kinds of women will help ensure that the information we get from research is complete and accurate.  Nearly every woman can qualify for a medical research study at some time in her life.  Even those who aren't sick are eligible and needed for studies; perfectly healthy people may participate in observational studies and Phase I (early stage) clinical trials.  If you are currently healthy but are at risk for a disease, you may qualify for a prevention study. And if you get sick, you may want to consider entering a clinical trial to test an investigational treatment.

Each medical research study is carefully designed to answer particular questions. Part of the design, known as the protocol, includes deciding what particular qualities a person must have in order to qualify for the study.  If you decide to volunteer for a study, the first step will be for the research coordinator to determine if you qualify. Examples of questions you might be asked include your age, whether you have the disease or risk of disease that is being studied, you have other diseases or conditions, you are taking other medications, and so on.

At that time, a member of the research staff will be able to answer important questions such as:

  • What is the purpose of the study?
  • Who will be in charge of your medical care?
  • Who has reviewed and approved the study protocol?
  • What are the possible effects of the study treatment and how do they differ from the standard treatment?

Medical research and clinical trials are the only ways to find new treatments for diseases and the only way to ensure that these treatments are safe and effective.  However, they cannot take place without the support and participation of volunteers. Choosing to take part in a medical research study is a decision only you can make with the help of family, friends, health care professionals, and others you trust and respect. And while study volunteers' efforts may not lead to an immediate cure for cancer, they are indeed the first stepping stone.

By calling the Society's toll-free number 1-877-33CANDO (1-877-332-2636) or visiting www.womancando.org on the Internet, women can request a free information kit about medical research studies. The kit and the website include a description of different types of medical research, a glossary of terms, and a list of resources to help you find studies that may interest you.

[1] Harris Interactive.  Misconceptions and lack of awareness greatly reduce recruitment for cancer clinical trials.  Harris Interactive Healthcare News. Issue 3 Highlights.  January, 2001

Created: 9/25/2001  -  Phyllis E. Greenberger

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