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.

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

• 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.
• Behavioral studies to evaluate ways of modifying cancer-causing behaviors, such as tobacco use.
• Genetic studies address how genetic makeup affects detection, diagnosis, and treatment of cancer.

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

Phase I trials are the first studies to evaluate how a new therapy should be administered - how often, and in what dosage. The focus is to determine safety (drug dose, device safety, or other therapy's safety) for the next phase of testing.

Phase II trials provide preliminary information about how well the new therapy 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 therapy, combination of treatments, or procedure with a current standard of treatment.

Phase IV trials include the continuing evaluation that takes place after approval by the U.S. Food and Drug Administration (FDA), when the therapy is already available for general use.

Large cancer centers, university hospitals, local medical centers, or physician offices may all 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.

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.

Always consult your physician for more information.

Greenwich Hospital patients who qualify have access to national clinical trials and through the Smilow Cancer Hospital affiliation with Yale Cancer Center.