Q: What are clinical trials?
A: Clinical trials are research studies conducted to answer important medical and scientific questions with the ultimate hope of finding better ways to treat diseases such as cancer. Clinical trials are used to evaluate the safety and effectiveness of new drugs (also known as investigational drugs or "study drugs"), combinations of new drugs or new combinations of existing drugs and drug delivery methods. Researchers offer these drugs or methods to patients because they hope the results will be as good as or better than the treatments currently being used.
Q: How are cancer research studies structured?
A: Cancer research studies are divided into several phases. Phase One studies generally represent the first time a drug is given to a patient. In Phase One studies, physicians are looking for several things, including the most appropriate drug dosage, the patient's tolerance of the drug, the side effects and the cancers most likely to respond to treatment utilizing the drug.
In Phase Two studies, a smaller number of patients with a particular type of cancer receive the study treatment at the dosage found to be safe in Phase One trials. The purpose of Phase Two studies is to better define the effectiveness and safety of study drugs in treating a specific type of cancer.
Only a small number of patients participate in Phase One and Two studies. A greater number of patients participate in Phase Three studies. Phase Three studies are designed to confirm the findings of the earlier studies with a larger patient group. Phase Three studies also compare the study treatment with treatments currently in use.
Q: Which phases involve University of Colorado Cancer Center physicians?
A: Our physicians are involved in several Phase One, Two and Three studies. They strongly believe that clinical research can help advance the delivery of care for patients like you as well as for future patients. Your physician may offer you participation in a clinical trial if he or she feels it is the best treatment option for you. Even though your physicians are involved in cancer research, the final decision to participate in a clinical trial is yours.
Q: What role will my physician play if I decide to participate in a clinical trial?
A: If you participate in a clinical trial, your physician and clinical care team will closely monitor every aspect of your care. Your physician fully understands the study treatment plan and the questions it addresses. A special research coordinator, who works directly with your physician and is dedicated to clinical trial patients, will also be involved.
Throughout the clinical trial, your needs as a patient come first. If there is no improvement in your condition or the treatment causes intolerable side effects, you and your physician may decide to discontinue the study and proceed with other available treatment options. Should you decide to withdraw from a clinical trial, your wishes will be respected without any effect on future treatment plans.
Q: How do I get more information about clinical trials?
A: Your physician has information on the clinical trials that are available to University of Colorado Cancer patients. Talk with your doctor to find out whether there is a trial that would be appropriate for your specific program of care. If so, your physician will explain the purpose and requirements of the study, including any potential drawbacks and benefits to you as a participant.