Mandated Benefits Review - Senate Bill 1198 - What is a Clinical Trial?

A cancer clinical trial is a research study which tests a new cancer treatment or therapy in the hopes of improving cancer treatment. There are several types of cancer clinical trials including:

Clinical trials may test a new drug, a type of surgery or radiation, a combination of treatments, or new treatments such as gene therapy. Clinical trials occur after laboratory research (and possibly animal research) has taken place. If the laboratory research appears promising, clinical trials are the studies done with patients to determine if the treatment is safe and effective for humans.

There are three main phases of clinical trials. Phase I trials are the first stage of human testing and involve a limited number of people. Phase I trials are conducted to determine if and how the new treatment may be given safely. For example, they help determine the appropriate dosage of a new drug. Doctors involved with Phase I trials closely monitor patients for any harmful side effects.

Phase II trials generally involve a particular type of cancer. They focus on the effect the proposed treatment has on cancer. For example, they may help determine if the treatment results in shrinkage of a tumor. Because the safety of the treatment is still under study, Phase II trials also involve only a small number of people.

Phase III trials are larger studies which may involve hundreds or thousands of people across the country. Phase III trials compare the results of the new, proposed treatment with the results of the standard treatment. They hope to determine which treatment produces fewer side effects and has higher success rates. In Phase III trials, patients are randomly assigned to either a treatment group (where they receive the new treatment) or to a control group (where they receive the standard treatment). Therefore, patients who choose to participate in Phase III trials do not necessarily receive the new treatment.

Once a new treatment has been proven safe and effective in a Phase III trial, the next step is to inform the general public. Trial results are also typically reported in a medical journal to let health professionals know of the new treatment.

Some people refer to Phase IV trials. These are ongoing studies conducted after a new drug or device has been approved by the Food and Drug Administration and is available for general use. Phase IV trials are a method of continually evaluating the drug to see if the results remain constant.

>Clinical trials are approved by the sponsoring organization and the Institutional Review Board at the participating hospital. Doctors will closely monitor a patient's progress and if the treatment shows harmful effects, the patient will be removed from the treatment immediately. One of the key patient protections in a clinical trial is informed consent. Patients are required to sign a form stating that they are aware of the details of the study and the possible risks and benefits of treatment. Participation in clinical trials is entirely optional for a patient and includes the option to leave the study at any point in time.