Each phase answers different questions about the new treatment.

Phase I trials are the first step in testing a new treatment in humans. In these studies, physicians and scientists aim to find a safe dose, decide how the new treatment should be given and see how the new treatment affects the human body and fights cancer.

Phase II trials focus on learning if the new treatment has an effect on a certain cancer and how the new treatment affects the body and fights cancer.

Phase III trials compare the new treatment (or new use of treatment) with the current standard-of-care treatment. In most cases, studies move into Phase III testing only after a treatment shows promise in Phases I and II trials. Phase III trials may include hundreds of people around the country.

Clinical trials give doctors and patients new tools in the fight against cancer. Clinical trials contribute to knowledge and progress against cancer. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Many of today’s most effective standard treatments are based on previous study results. Clinical trials may also answer important scientific questions and suggest future directions in cancer research.

Just as important, patients who volunteer for clinical trials may be personally helped by the treatment they receive throughout the course of the trial. They get up-to-date care from cancer experts, and they receive either a new treatment being tested or the best available standard treatment for their cancer.

While there is no guarantee that a new treatment being tested or a standard treatment will produce good results, if a new treatment proves effective or more effective than standard treatment, study patients who receive it may be among the first to benefit. Some patients receive only standard treatment and benefit from it.

When you take part in a clinical trial, you receive your treatment in a cancer center, hospital, clinic and/or doctor’s office. Doctors, nurses, social workers and other health care providers may be part of your care team. They will follow your progress closely. You may have more tests and doctor visits than you would if you were not taking part in a study.

You will follow a treatment plan prescribed by your doctor, and you may have other responsibilities such as keeping a log or filling out forms about your health. Some studies continue to check on patients even after their treatment is over.

Deciding whether or not to enroll in a clinical trial is a question only you, your loved ones and your care team can answer together. Learning you have cancer and deciding what to do about it is often overwhelming, so talking with those closest to you and your treatment plan can help you understand all aspects of participating in a clinical trial, including the benefits and drawbacks, your protections as a patient and any financial and/or insurance considerations.

Finding answers and making choices may be hard for people with cancer and those who care about them. It is important to discuss your treatment choices with your doctor, your oncologist and the staff of any clinical trial you consider entering.

Ask questions about the information you receive during the informed consent process and about any other issues that concern you. Getting answers can help you work better with the doctor. You may want to take a friend or relative along when you talk to the doctor. It also may help to write down your questions and the answers you receive, or bring a tape recorder to record what is said. No question about your care is foolish. It is very important to understand your choices.

Here are some questions you may want to ask:

About the study:

• What is the purpose of the study? In what phase is this study?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
• Who sponsors the study, and who has reviewed and approved it?
• How are the study data and patient safety being checked?
• When and where will study results and information go? Possible Risks and Benefits
• What are the possible short- and long-term risks, side effects, and benefits to me?
• Are there standard treatments for my type of cancer?
• How do the possible risks, side effects, and benefits in the study compare with standard treatment?

About your care:

• Where will my treatment take place? Will I have to be in the hospital? If so, how often and for how long?
• How will I know if the treatment is working?
• Will I be able to see my own doctor? Who will be in charge of my care?

About your life:

• How could the study affect my daily life?
• Can you put me in touch with other people who are in this study?
• What support is there for me and my family in the community?

About the cost:

• Will I have to pay for any treatment, tests, or other charges?
• What is my health insurance likely to cover?
• Who can help answer any questions from my insurance company or managed care plan?

For questions regarding cancer, you may contact Cancer Answers and speak with an Oncology Nurse, 1-800-UAB-0933.