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What are Clinical Trials?

Clinical trials are research studies conducted with people who volunteer to take part. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. People who take part in cancer clinical trials have an opportunity to contribute to knowledge of, and progress against, cancer. They also receive up-to-date care from experts.
Clinical trials, also called cancer treatment studies or research studies, test new treatments in people with cancer. Clinical trials test many types of treatments such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy. The goal of this research is to find better ways to treat cancer and help cancer patients. There are different types of clinical trials, called Phase I, Phase II, and Phase III trials. Each is one of the final stages of a long and careful cancer research process. If your doctor does not suggest you take part in a clinical trial, you may want to ask about clinical trials as a treatment choice for you.

What are the types of clinical trials?

Prevention trials study ways to reduce the risk, or chance, of developing cancer. Most prevention trials are conducted with healthy people who have not had cancer. Some trials are conducted with people who have had cancer and want to prevent the return of cancer (recurrence), or reduce the chance of developing a new type of cancer.

Screening trials study ways to detect cancer. They are often conducted to determine whether finding cancer before it causes symptoms decreases the chance of dying from the disease. These trials involve people who do not have any symptoms of cancer.

Diagnostic trials study tests or procedures that could be used to identify cancer more accurately and at an earlier stage. Diagnostic trials usually include people who have signs or symptoms of cancer.

Treatment trials are conducted with people who have cancer. They are designed to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard treatment. These trials test many types of treatments, such as new drugs, vaccines, new approaches to surgery or radiation therapy, or new combinations of treatments.

Supportive care (or quality of life) trials explore ways to improve the comfort and quality of life of cancer patients and cancer survivors. These trials may study ways to help people who are experiencing nausea, vomiting, sleep disorders, depression, or other effects from cancer or its treatment.

Genetics studies are sometimes part of another cancer clinical trial. The genetics component of the trial may focus on how genetic makeup can affect detection, diagnosis, or response to cancer treatment.

Population- and family-based genetic research studies differ from traditional cancer clinical trials. In these studies, researchers look at tissue or blood samples, generally from families or large groups of people, to find genetic changes that are associated with cancer. People who participate in genetics studies may or may not have cancer, depending on the study. The goal of these studies is to help understand the role of genes in the development of cancer.

Possible benefits of clinical trials include:

Clinical trials offer high-quality cancer care.

  • If a new treatment approach is proven to work and you are taking it, you may be among the first to benefit.
  • By looking at the pros and cons of clinical trials and other treatment choices, you are taking an active role in a decision that affects your life.
  • You have the chance to help others and improve cancer treatment.

Possible drawbacks:

New treatments under study are not always better than, or even as good as, standard treatment.

  • Even if a new treatment has benefits, it may not work for you.
  • In a study, if you are randomly assigned to have standard treatment instead of the new treatment being tested, it may not be as effective as the new approach.
  • Health insurance and managed care providers do not always cover all patient care costs in a study.

Before deciding to join a clinical trial you will want to ask important questions such as: What are the possible short- and long-term risks, side effects, and benefits to me? How could the study affect my daily life? Will I have to pay for any treatment, tests, or other charges?

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