What are clinical trials?
Clinical trials are studies, managed by government agencies, educational institutions, private not-for-profit organizations, or commercial businesses, to develop, produce, and evaluate the effectiveness of new treatments and therapies for diseases.

What are types of clinical trials?
According to the National Cancer Institute, there are different types of cancer clinical trials, including:

• prevention trials designed to keep cancer from developing in people who have not previously had cancer.

• prevention trials designed to prevent a new type of cancer from developing in people who have had cancer.

• early detection trials to find cancer, especially in its early stages.

• treatment trials to test new therapies in people who have cancer.

• quality of life studies to improve comfort and quality of life for people who have cancer.

• studies to evaluate ways of modifying cancer-causing behaviors, such as tobacco use.

What are the phases of a clinical trial?
Most clinical research progresses in an orderly series of steps or phases.

Clinical Trials for Breast Cancer Research

There are many breast cancer clinical trials and studies underway across the United States -- and in other countries. They are sponsored by government agencies, healthcare organizations, private industry, and non-profit foundations -- working together in an unprecedented spirit of collegial and collaborative cooperation.

In this country, trials and studies are overseen by the government, under the auspices of the Department of Health and Human Services, National Institutes of Health, Food and Drug Administration, and others. Most breast cancer trials are managed under the guidance of the National Surgical Adjuvant Breast and Bowel Project (NSABP).

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Breast Cancer Prevention Trial

Study of Tamoxifen and Raloxifene

• Phase I trials are the first studies to evaluate how a new drug should be administered (orally, intravenously, by injection), how often, and in what dosage.

• Phase II trials provide preliminary information about how well the new drug works, and generates more information about its safety and benefits. A Phase II study usually focuses on a particular type of cancer.

• Phase III trials compare a promising new drug, combination of drugs, or procedure with a current standard of treatment.

• Phase IV trials include the continuing evaluation that takes place after FDA approval, when the drug is already on the market and available for general use (post-marketing surveillance).

What is a clinical trial protocol?
Clinical trial protocols are the action plans or guidelines that must be followed during the course of any study. Guidelines may cover:

• the design of the study -- what it will study and how
• who may participate -- criteria for patients who enter the study
• what medications and medical tests will be used to follow the participants
• what information is being searched for

Several research centers may be involved in the study, and each uses the same protocols to ensure that information from all centers can be combined and compared.

Where are trials conducted?
Large cancer centers, university hospitals, local medical centers, or physician offices, all may be included in managing clinical trials. There may be only one or two locations involved in a particular study, or hundreds around the country.

Who can participate in a trial?
Each protocol in a trial defines specific characteristics, called eligibility criteria, that participants should have in order to participate in the study. Characteristics may include type of disease and its stage, as well as the participant's age and general health.

Eligibility criteria help assure that the study results answer the research question and identify who will benefit in the future from the approach being studied.

How are trial participants protected?
There several procedures in place, as part of the protocols, to protect the safety of the people who participate. Two groups that oversee the safety procedures are the:

• organization that sponsors the study, for example, the National Cancer Institute

• Institutional Review Board (IRB) that oversees clinical research in the healthcare institution. The IRB includes physicians, other health care providers, consumers, and sometimes members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that participants are not likely to be harmed.

Phase III trials also have a special group called a Data Safety and Monitoring Committee that looks at the test results, monitors the safety of the participants, and decides whether the study should go forward as originally planned.

For information on how to participate in a clinical trial, please talk with your physician.

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