About Clinical Trials

Conditions A-Z - About Clinical Trials: Information from the National Cancer Institute

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, health care organizations, private industry, and nonprofit 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, FDA, and others. Most breast cancer trials are managed under the guidance of the National Surgical Adjuvant Breast and Bowel Project.

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 some types of clinical trials?

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

What are the phases of a clinical trial?

Most clinical research progresses in an orderly series of steps or phases.

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:

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 doctor offices; all may be included in managing clinical trials. Informed consent is a process designed to protect potential participants through detailed description of important facts about a specific clinical trial. There may be only one or two locations involved in a particular study, or hundreds around the country, or even around the world.

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 are several procedures in place, as part of the protocols, to protect the safety of the participants. Informed consent is a process designed to protect potential participants through detailed description of important facts about a specific clinical trial. Two groups that oversee the safety procedures are the:

Some clinical trials, especially 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 doctor.

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