Second Annual Womens Health Conference
What is a Clinical Trial?
Clinical trials, or research studies, involve medical research with people. Most medical research begins with studies in test tubes and in animals. Treatments that show promise in these early studies may then be tried with people. The only sure way to find out whether a new treatment is safe, effective, and better than other treatments is to try it on patients in a clinical trial.
A clinical trial is a method of testing different medications, treatments or products to determine which ones are safe and effective. There is a difference between being treated by your health care team and clinical trials. The primary goal of a health care team is to help the patient stay healthy. While a study participant's health is an essential part of clinical trials, the primary goal is to find out which treatments work for the most people.
Lots of different people participate in clinical research and they are selected in various ways. In most cases, participants are volunteers who meet special criteria determined by the research study's purposes. Every study identifies some specific characteristics, called eligibility criteria, that the participants should have in order to participate in the study. They may include a diagnosis with a particular type of disease, the presence of certain symptoms, the absence of certain diseases or conditions, age and general health. Eligibility criteria are a key part of medical research.
Patients in a clinical trial are expected to have exams and other tests. They may also need to take medications and/or undergo surgery. Depending on the treatment and the examination procedure, a hospital stay may be indicated. Follow-up examinations at the medical facility also may be necessary. These exams help find out how well the treatment is working. Follow-up studies can take months or years. However, the success of the clinical trial often depends on learning what happens to patients over a long period of time. Only patients who continue to return for follow-up examinations can provide this important long-term information.
Ideas for clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.
The process depends on the kind of trial in which you participate. The team will include doctors and nurses as well as social workers and other health care professionals. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study. Some trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work with a research team. Your participation will be most successful if you follow instructions carefully and stay in contact with the research staff.
Clinical trials are conducted in four phases and different groups of people are selected for each phase:
In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
Clinical trials can be funded by pharmaceutical companies, the federal government, individual physician-investigators; health care institutions such as health maintenance organizations (HMOs); and organizations that develop medical devices or equipment. They can take place in a variety of locations, such as universities, hospitals, doctor's offices and clinics. The research services and research medications or products received in most clinical trials should be free. Some clinical trials will pay you for joining the trial, while others will not. In some programs, researchers will reimburse you for expenses associated with participating in the research, including transportation costs, child care, meals and accommodations.
To Find Out More About Clinical Trials
You can find out about research studies in several ways. Sometimes researchers place advertisements and announcements in newspapers or on the radio, especially in larger cities. Other times, your own health care provider may be conducting research herself, or may know of current research studies.
One of the more recent ways to learn about current studies is through the Internet. The federal government and other groups have made databases of current research studies available just a mouse click away. Some of the sites even allow a person to fill out an information form and to ask questions online. A helpful site sponsored by the Society for Womens Health Research (www.womencando.org) has a great deal of information about clinical trial participation for women. The Food and Drug Administration maintains a Web site (http://www.fda.gov/cder/) with anything you want or need to know about FDA-approved drugs and the FDA approval process.
Regardless of how you find out about a clinical trial, if you think you are interested in participating, you should contact the research study office. The research staff will ask some questions to see if you meet the eligibility criteria for that particular study and you may have to come in for initial tests or exams. Contact information for clinical trial sponsors are listed below.
Cancer Clinical Trials
For more information about cancer clinical trials, talk with your doctor or call the Cancer Information Service (CIS) at 1-800-4-CANCER, or visit the National Cancer Institutes clinical trials website at . The CIS can send you a booklet on clinical trials and information about specific studies in your area.
Clinical Trials and Insurance Coverage
As you consider enrolling in a clinical trial, you will face the issue of how to cover the costs of care. You should find out about all costs ahead of time. In some clinical trials, the medical facility conducting the research pays for treatment costs and some other expenses. You or your health insurance may have to pay for some things that are considered part of standard care. These things may include hospital stays, laboratory and other tests, and medical procedures. You also may need to pay for travel between your home and the clinic.
If you have health insurance, find out exactly what it will cover, as your coverage may not include some or all of the costs associated with a clinical trial. This is because some health plans define clinical trials as "experimental" or "investigational" procedures. Lack of coverage for these costs often keep people from enrolling in trials. If you don't have health insurance, or if your insurance company will not cover your costs, talk to the clinic staff about other options for covering the cost of your care.
There are two types of costs associated with a trial: patient care costs and research costs.
Patient care costs fall into two categories: usual care costs, such as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., which occur whether you are participating in a trial or receiving standard treatment; and extra care costs associated with clinical trial participation, such as the additional tests that may or may not be fully covered by the clinical trial sponsor and/or research institution. Insurance companies have been reluctant to pay for costs associated with patient care because they can be expensive and because the treatment might cause additional health problems for the patient.
Research costs are those associated with conducting the trial, such as data collection and management, research physician and nurse time, analysis of results, and tests purely performed for research purposes. Such costs are usually covered by the sponsoring organization.
In Illinois, Governor George Ryan recently signed legislation requiring insurance companies to offer the option of coverage for "investigational" cancer treatments, which would include routine patient care in connection with clinical trials. The law will provide a transitional period (until January 1, 2003) to determine whether insurance coverage for routine patient care costs associated with "investigational" cancer treatment is a practical solution to the difficulties individuals face when they are seeking treatment. It allows insurers to set an annual benefit limit of $10,000 for routine patient care associated with the investigational cancer treatments and requires that the costs of the treatment be paid by the sponsor of the clinical trial. The bill requires the Illinois Department of Insurance to conduct a study of the costs and benefits of establishing coverage for investigation cancer treatments. Results of the study must be submitted to the Governor and the General Assembly by March 1, 2003.
At the federal level, President Clinton recently announced that Medicare will revise its payment policy to reimburse the routine patient care costs of clinical trials. The change means that 40 million seniors will have access to clinical trials, a move that could speed new treatments into regular use. Current policy discourages Medicare from paying for routine patient care costs. The President directed the U.S. Department of Health and Human Services to immediately begin reimbursing claims for routine patient care costs of clinical trials. In addition, the order initiates an education campaign aimed at Medicare beneficiaries and providers, and directs DHHS to track Medicare clinical trials spending.
Benefits and Risks of Clinical Trial Participation
There are both benefits and risks associated with clinical trials, and you should be aware of both before participating.
If you decide to participate, the benefits you receive will depend not only on the specific study in which you enroll but also on the part of the study to which you are randomly assigned. By participating in a clinical trial, you can
You should also consider that there may be potential risks when participating in research, especially if you are randomized to the treatment group of a clinical trial. The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board to make sure the risks are as low as possible and are worth any potential benefits.
Well before a clinical study begins, the researcher has attempted to reduce any risk of physical discomfort or harm to you and others who take part. Yet, for research to be absolutely "risk-free," every possible outcome would have to be known and if it were, then the research would not be necessary.
Various different causes or forms of discomfort could result from a particular research study. A patient/subject may have to take off from work, or pay for some of the treatment. The protocol may require a lot of time for trips to the study site, treatments, hospital stays, or complex dosage requirements. If a new drug or procedure is being tested, it may have side effects, adverse reactions or risks unknown to the doctors; or the side effects and results may be worse than those from interventions that are currently used. Even if a new approach has benefits, it may not work for you.
Some discomforts may be like what you are used to in routine health care, such as a needle prick when blood is drawn for testing purposes. However, sometimes a research design may call for more uncomfortable procedures, procedures with known risks, or procedures for which the risk may not be fully known. These could include, for example, being deprived of sleep, receiving injections, having a spinal tap, receiving a small dose of a radioactive substance needed for a brain scan, or treatment with an investigational drug.
Remember, nothing is without risks, including illness itself, and risks in clinical research are minimized as best as possible. You should ask and be told about any foreseeable risks or discomforts that may occur in the research before you agree to participate.
Special Issues for Women in Clinical Trials
Between 1977 and 1993, the FDA prohibited the inclusion of women of childbearing age in the early phases of research studies that tested new drugs, unless the woman had a life-threatening disease. The FDA was concerned about the possible effects of experimental drugs on fetuses. It is possible to reduce the risk of fetal exposure through study design. By either administering the drug during or immediately following a woman's menstrual period or after a pregnancy test, or by counseling women in trials about the need to use reliable forms of contraception, the potential risk to fetuses can be avoided. However, many women of childbearing age are unlikely to get pregnant. For instance, women using oral, injectable, or mechanical contraception, women whose partners have had vasectomies, women who are not sexually active, and lesbians are not likely to get pregnant.
Additionally, it is better to know if a drug affects fetuses or affects pregnant women differently by testing the drug in a small number of pregnant women than for drugs to be used by many women during pregnancy without reliable information on their maternal and fetal effects.
There are important scientific benefits to including women in early phases of drug research. If sex differences in the way a drug works are identified in early phases of the research, then subsequent studies can be designed more suitably so that researchers can figure out how the drug should be used to benefit women.
Governors Commission on Women Brochure Available
In his first executive order, Governor George Ryan created the 25-member Governors Commission on the Status of Women in Illinois. Lieutenant Governor Corinne Wood serves as the honorary chair and Judy Gold as chair. The Commission is organized into eight working groups revolving around the key issues that affect Illinois women and girls. Each working group is chaired by one or two Commissioner(s) who are aided by relevant agency liaisons. The remaining members of the working groups are men and women who have knowledge and expertise in the various issues areas.
The Health Working Group is cochaired by Barbara Shaw (Illinois Violence Prevention Authority) and Joyce Nardulli (Illinois State Medical Society). Sharon Green, deputy director of the Office of Womens Health, serves as the agency liaison for the group.
The commission recently published a colorful and informative brochure on womens health prepared by the Health Working Group. It is divided into three sections. The first section is a summary of the key provision of the Managed Care Reform and Patients Rights Act passed by the General Assembly last year, including numbers to call if someone feels her or his rights may be denied. The second section is a list common health screening tests recommended for women as well as age and frequency guidelines. The final section summarizes the commissions legislative health priorities for the coming year.
Copies of this comprehensive booklet can be obtained for free by calling Emily Duft in the Office of Womens Health at 312-814-7098.
OWH Offers Womens Health Initiative Grants
The Illinois Department of Public Health-Office of Womens Health (OWH) has funds available to support community activities addressing womens health. The fiscal year 2002 program areas are cardiovascular disease, community planning for womens health, eating disorders, menopause and osteoporosis. Eight model programs that target these program areas have been selected from past OWH grant recipients and are available for review by prospective applicants who wish to address similar needs among the women in their communities.
The Womens Health Initiative is offering the following programs for fiscal year 2002:
Proposals are due on Thursday, March 15, 2001. The funding period is July 1, 2001 through June 30, 2002. You may download a copy of the Request for Application from the IDPH website at or contact the Office of Womens Health at 217-524-6088.
Workshops to help potential applicants will be held in three locations: February 6 in Springfield, February 8 in Chicago, and February 15 in Mt. Vernon. For more information, please contact Phallisha Curtis in the OWH office.
Womens HealthBeat Fact Sheets
Fact sheets on several womens health topics are available from the Office of Womens Health. You may order a complete set of fact sheets (or individual topics) by calling the OWH Helpline 1-888-522-1282 or faxing your request to 217-557-3326.
Topics include: alzheimers disease, arthritis, breast cancer, cervical cancer, colon cancer, date-rape drugs, depression, domestic violence, eating disorders, endometrial (uterine) cancer, endometriosis, fibroids, heart disease, HIV, hysterectomy, lung cancer, menopause, osteoporosis, ovarian cancer, sexually transmitted diseases, smoking, stroke, urinary tract infections, vaginitis and vaginal infections, violence against women, womens wellness-nutrition, womens wellness-exercise.
The OWH encourages you to make copies of the fact sheets for distribution to your constituents.
Focus on Office of Womens Health Grant Programs
This year the Office of Womens Health provided funding to 58 local agencies to do womens health programming on a variety of subjects. Upcoming issues of the newsletter will focus on at least one project, not only to highlight the good work they are doing, but because the project may have materials or other elements you may want to replicate.
White Crane Wellness Center
White Crane was founded as an independent non-profit organization in 1989 by a multi-ethnic coalition of senior activists centered in Chicagos Lakeview neighborhood. Supported by leading figures in the local business, political and health care communities, the coalition has a dual goal: (1) to provide direct health and wellness services to older adults seeking ways to improve their health; and (2) to serve as a national model for a new approach to health and aging. White Crane sustains a membership base of nearly 600 seniors, and reaches a combined audience of 15,000 a year. It provides health and wellness (health promotion and disease prevention) programming to seniors who live in Rogers Park, Uptown, Albany Park, Edgewater, and surrounding neighborhoods.
With its Womens Health Initiative funding, White Crane provides services to older low-income, minority, immigrant and refugee women. The center provides health education, exercise classes, screenings, referrals and counseling at 15 low-income senior living facilities and ethnic community service centers. Their womens health grant allows them to provide programs in 10 languages.
White Crane has become recognized throughout Illinois and nationally as an innovative model for a new approach to health and aging. Last September, the center received the SHARE Award, presented by the University of Pennsylvania/Institute on Aging and SmithKline Beecham for excellence and leadership in providing health and wellness services for diverse groups of elders.
White Crane provides an amazing amount of services with a small budget. Expert in leveraging resources within the community, staff are willing to share their experience in building partnerships and communicating with hard-to-reach populations.
As part of their educational efforts, White Crane staff have worked with the Coalition of Limited English Speaking Elderly (CLESE) to translate health information into several languages. If you are interested in receiving any of the materials, please contact Elizabeth Cagan at 773-271-9001.
OWH staff had read White Cranes grant applications, kept track of its quarterly reports last year and now, in the second year of its grant, decided to see for ourselves the wonderful services that have been provided since the center opened its doors in 1989. In October, Sharon Green and I met with executive director, Elizabeth Cagan, and its project coordinator, Michael Svete, and happily accepted the invitation to visit the Sheridan/Devon senior building.
Most of the seniors living in this apartment complex had immigrated from Russia within the last 10 years. Patriotic music, unfamiliar to us, greeted us as we opened the door to the activity room. About 15 senior women were seated in a circle of folding chairs, imitating the motions of a muscular young African American man, Troy Ford. Troy sat in the center of the circle, cheerfully calling out commands in English. The women raptly watched him and obviously were enjoying the routine, moving their arms and feet in unpracticed motion. When they were finished with their chair exercises, he stood and the women mirrored his motions as he steadied himself against the back of a chair and lifted his left leg to the front, one-two, then back, three-four. Fifteen beautiful women who had been lonely and isolated were now engaged in activitylike a Saturday night dancehaving fun, feeling social, being energized. When the exercise session was over, we learned the women had brought him a card and a bottle of champagne to celebrate his 32nd birthday that day! They were proud they had surprised him and fondly wished him a happy birthday in Russian dialects as he packed up his boom box and jacket and left.
After a short break, Julia Khomutov, a petite nurse, six months pregnant, began talking to the women in Russian about breast examinations and breast cancer. She helped them feel comfortable thinking about touching their own bodies. They trusted her with their questions and stayed after the session to have their blood pressure checked and received the attention and case management that Julia provides.
We delighted in watching the whole experience and felt good about the grant funding that makes these services possible.