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Clinical Studies Cancer Research in the Clinic: Who, What, Where, and Why Cancer death rates are falling in the United States. This good news stems partly from the patient studies clinical studies or clinical trials that over the years have developed better treatments for many different cancers, including breast cancer, colon and rectal cancer, childhood cancers, Hodgkin's disease, and testicular cancer. Today, thousands of researchers and patients throughout the United States are involved in clinical studies to continue development of better treatments. What does "clinical trial" mean? "Clinical trial" is a research term that refers to medical studies with people. These studies are the final step in the process of developing new drugs and other means to fight disease. Once a drug has shown promise, first in laboratory and then in animal studies, it may move on to studies with people if the U.S. Food and Drug Administration (FDA) approves. At this stage, FDA approval is to conduct the study - not for the drug itself. Only after a drug proves safe and effective in clinical studies does FDA grant approval for marketing the drug. What is a clinical study? In cancer research, a clinical study is designed to show how a particular anticancer strategy for instance, a promising drug, a new diagnostic test, or a possible way to prevent cancer affects the people who receive it.
Where do clinical studies take place? All over the country. These studies take place in cancer centers, other major medical centers, community hospitals and clinics, and veterans' and military hospitals in numerous cities and towns around the United States. Hundreds of clinical studies are carried out by large networks, called cooperative clinical trial groups, that are funded by the National Cancer Institute (NCI). The cancer specialists, or oncologists, who belong to these networks conduct joint studies simultaneously in many different places and pool their data.
What are the different kinds of clinical studies? Prevention studies look at lifestyle changes or drugs that may help prevent cancer. One study, for example, is testing a drug that may prevent breast cancer in women at high risk. Diagnostic studies look at ways of detecting cancer or finding out more about a tumor. For instance, a large study is looking at new ways to analyze Pap tests, the common screening test for cervical cancer, along with different ways of following up on Pap test abnormalities. Treatment studies may study new drugs or other ways of treating cancer, or they may look at new combinations of established treatments. Treatment studies fall into three categories:
One example of a treatment study is a phase II study of the drug Taxol® in combination with cisplatin to treat advanced or relapsed lung cancer.
What are the benefits of taking part in a study? One advantage, of course, is the possibility that a new treatment, diagnostic test, or preventive measure will turn out to be better than a more established procedure. Patients who take part in procedures that do prove to be better have the first chance to benefit from them. In phase III clinical studies where one treatment is compared to another, patients receive either the most advanced and accepted treatment for the kind of cancer they have known as the "standard" treatment or a new treatment that has shown promise of being at least as beneficial as the standard treatment, if not better. People who take part in studies receive specialized care under a very detailed set of directions or protocol. Highly trained and experienced cancer specialists design, review, and approve each protocol. In addition, all clinical trial patients are carefully monitored during a study and followed afterwards. They often become part of a network of clinical studies carried out around the country. In this network, doctors and researchers share their ideas and experience, so patients receive the benefit of their pooled knowledge. Many cancer patients have said that they take part in studies also because it is an opportunity to contribute to new knowledge that may benefit others with cancer.
What are the risks? Medical studies can carry unknown dangers and side effects, as well as hoped-for benefits. Many medical treatments have known side effects, but because clinical studies are testing new treatments, the risks involved are not always known ahead of time. The risks and benefits of each study are explained in a document, called an informed consent form, that patients discuss with their doctors or nurses before agreeing to participate.
What safeguards are there for patients? Any well-run clinical study is carefully reviewed for medical ethics, patient safety, and scientific merit. An institutional review board (IRB), located at the institution where the study is to take place, must review the study before it begins. Made up of scientists, doctors, clergy, and other people from the community, IRBs focus on minimizing risks to patients. They also ensure that any patient interested in the study will be able to make an informed decision about participation. Careful monitoring of side effects during the study is another safeguard. In addition, NCI conducts regular reviews of studies it sponsors, and FDA requires regular reports on all clinical studies, including those that are investigating cancer treatments.
What about costs? Do insurance or managed care plans cover the cost of participation? Costs are a major concern of cancer patients and their families. Different arrangements and policies exist at different research institutions. Health insurance programs also vary; some cover part or all of the cost of care in a study, some make decisions on a case-by-case basis, and some never or rarely cover clinical study costs. NCI is now working with major managed care and health insurance programs to encourage coverage for cancer patients who want to enroll in a study. How to find out about clinical studies Clinical studies are under way for nearly every kind of cancer. To find out what they are and where they are taking place: Call NCI's Cancer Information Service (CIS) at 1-800-4-CANCER (1-800-422-6237) and ask for a customized search of the PDQ database, which provides information on current studies. Also ask for the pamphlet, What Are Clinical Trials All About?, which tells more about these studies, including questions to ask before deciding to participate. Log on to the World Wide Web at: http://cancernet.nci.nih.gov, the homepage of NCI's International Cancer Information Center (ICIC), which provides access to the PDQ database as well as current information on preventing, diagnosing, and treating cancer. Contact patient advocacy and voluntary organizations that may have information on studies of specific cancers. Some cancer patient organizations are now preparing succinct, nontechnical summaries of clinical trials in conjunction with NCI. The first 150 summaries, which describe breast cancer studies, are now available via the homepage of the National Association of Breast Cancer Organizations (www.nabco.org) and the ICIC homepage (wwwicic.nci.nih.gov). The Cancer Information Service provides a nationwide telephone service for cancer patients, and their families, the public, and health care professionals. The toll-free number is 1-800-4-CANCER (1-800-422-6237); services are provided in English and Spanish. People with TTY equipment may call 1-800-332-8615. |
