What Are Clinical Trials?

What are clinical trials?

Clinical trials are research studies in which people choose to participate to help doctors find ways to improve health and cancer care. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer.

Why are there clinical trials?

Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective. A clinical trial is one of the final stages of a long and careful cancer research process.

What are the different types of clinical trials?

• 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.
• Prevention trials test new approaches that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer or stop cancer from coming back. Approaches may include medicines, vitamins, minerals, or other supplements.
• Screening trials review patient information to determine the best way to find cancer, especially in its early stages.
• Diagnostic trials study tests or procedures that could be used to identify cancer more accurately. Diagnostic trials usually include people who have signs or symptoms of cancer.
• Quality of Life trials explore ways to improve comfort and quality of life for cancer patients and cancer survivors.

What are the phases of clinical trials?

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug while protecting the patients' rights. Most clinical trials are classified into one of three phases:

• Phase I trials: These studies evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. Because this is the first step of research testing in human subjects, a phase I trial usually enrolls only a small number of patients. Currently, Phase I cancer clinical trials are not offered at Beaumont Hospitals. Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. A larger number of people are enrolled in this type of trial.
• Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
• Phase IV trials: After a treatment has been approved and is being marketed, the manufacturer may choose to further study the effects. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.

Beaumont Hospitals participate in Phase II, III, and IV Cancer Clinical Trials.