Registry Aims to Improve Women¹s Health for Future Generations

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Source: Cedars-Sinai Medical Center Released: Wed 12-May-2004,

06:40 ET

Registry Aims to Improve Women¹s Health for Future Generations

Description

More than 10,000 participants are expected to enroll in Cedars-Sinai Medial

Center¹s Women¹s Health Research Registry in the next five years. The

registry has been established in an effort to close the gap in the

under-representation of women in clinical research.

Newswise ‹ Seventy-year-old Trudi Butts is passionate about participating in

clinical trials. Her enthusiasm stems from something unexpected that

occurred while she was participating in a clinical trial in 1996. Laboratory

tests done as part of a study on estrogen confirmed that she had Hepatitis

C, a potentially life-threatening liver condition she didn¹t know she had.

Further tests suggested that she probably contracted the disease from a

blood transfusion she received almost 30 years earlier. She considers that

unrelated laboratory discovery to be blessing that helped fuel her current

attitude about clinical studies.

Recently she learned about Cedars-Sinai¹s Women¹s Health Research Registry,

an ongoing project of the Cedars-Sinai Medical Center Women¹s Guild, which

expects to enroll for clinical research more than 10,000 participants over

the next five years. The registry has been established in an effort to close

the gap in the under-representation of women in clinical research. ³I filled

out the questionnaire immediately and sent it in, as it is a wonderful

opportunity to make a significant contribution to the body of knowledge that

results from clinical trials,² she said. She hopes her enrollment will

persuade other women ­ especially African-Americans like herself ­ to

participate in clinical trials.

Clinical trials are research studies that test new scientific ideas, drugs

or treatments. For many years they didn¹t include women because it was

assumed that if a treatment worked for men, it would work the same way for

women. It¹s been just in the last 10 years that scientists have begun to

uncover significant biological and physiological differences between the

sexes.

According to C. Noel Bairey Merz, M.D., Director of the Registry, the

Women¹s Health Program and the Preventive and Rehabilitative Cardiac Center

at Cedars-Sinai, ³Gender-based research is showing evidence that drugs or

diseases may affect people differently based on their sex and that some

drugs or therapies may not be as effective in women as in men.

Cedars-Sinai¹s Women¹s Health Research Registry aims to bring about a

greater balance in the numbers of male and female trial participants in

clinical trials.²

There are more than 600 research projects underway at Cedars-Sinai¹s Burns &

Research Institute. Dr. Bairey Merz is Chair of a national,

multi-center study called Women¹s Ischemic Syndrome (WISE) that received its

initial funding in 1997 from the National Institute of Health¹s National

Heart, Lung, and Blood Institute. The study is designed to determine if

previously accepted information gleaned from research conducted on men with

coronary artery disease is useful in diagnosing women with heart disease.

³We¹re looking for women with varying backgrounds, with or without current

medical conditions, who are willing to consider participating in research

studies,² says Dr. Bairey Merz. ³Women represent 51% of the population yet,

surprisingly, we know very little about their health and aging. The registry

will allow qualified investigators to identify potential participants for

their studies and, in the long term, will contribute to the future of

medicine,² she says.

Many common health conditions experienced by both women and men are being

managed by treatments that were developed and tested mostly in men, Dr.

Bairey Merz adds. This is noteworthy in light of current data showing that:

Heart disease kills 50,000 more women than men each year; women smokers are

more likely to develop lung cancer than men smokers; and three out of four

people suffering from autoimmune diseases such as multiple sclerosis,

rheumatoid arthritis, and lupus, are women.

Women who volunteer to participate in the Registry are asked to complete a

questionnaire that includes a brief medical and lifestyle history that is

used to evaluate their current medical condition (if any) and to match their

information for ongoing and future research studies. Personal information,

such as a woman¹s name, is removed from the medical information and kept

separate for confidentiality purposes.

³What we call Œidentifiable information¹ is not made public, but shared only

with researchers who are investigating diseases or conditions that may

impact women,² explains Nosakowski, research coordinator. ³Only after

the registrant consents is her Œidentifiable information¹ given to the

researcher.²

There are several types of clinical trials, Nosakowski explains. Some are

carried out with healthy participants and others enroll only patients with

certain problems or conditions who may be helped by the treatment they

receive. Some are aimed at prevention, while others look at new or

alternative treatments, ways to detect specific diseases or procedures that

could be used to diagnose diseases more accurately. The U.S. Food and Drug

Agency regulates clinical trials and gives investigators permission to

conduct tests under strict regulatory conditions.

Some women, Nosakowski says, want to participate in clinical studies because

they have a strong family history of a particular disease or condition.

Others do it purely for altruistic reasons. Blake Sakow, in her late 20¹s,

is a marketing consultant with an in-home care company for senior citizens.

She was intrigued by the idea of a research registry geared for women. ³My

mother suffers from fibromyalgia (a form of rheumatism) and there¹s so

little known about it. I hope my participation in the Cedars-Sinai Research

Registry will in some way help her and maybe myself later along the way.²

Another Registry participant¹s interest was piqued after hearing Dr. Bairey

Merz cite several studies showing that women often don¹t receive the same

levels of preventative or symptom-related medical treatment as men. Carmen

enrolled in the Registry in March, even though she doesn¹t have a

family history of any disease. ³I have three daughters. That¹s reason

enough,² she says.

³We want our participants to feel that they are helping to find the answers

for important questions in medicine,² Dr. Bairey Merz adds. ³By encouraging

more women to participate in clinical trials, we¹re insuring that future

research is available for both genders.² To enroll in the Registry or for

more information, contact Nosakowski at the Cedars-Sinai Women¹s

Health Resource Center at (310) 423-9224.