Deciding to Join a Clinical Trial

As the patient, it is your decision whether to take part in a clinical trial. Ask as many questions as you need to ask until the answers are clear to you. Here are some questions you may want to ask your doctor.

What are the benefits and risks of participating in a clinical trial?

Each clinical trial has its own benefits and risks. You may benefit from joining a clinical trial in one of the following ways:

• If the new treatment works, you may be one of the first people to benefit.
• You may be able to help future cancer patients.
• The trial sponsor may pay for some of your medical care or tests. (Ask your patient access specialist about who pays for these costs before you agree to join.)
• Cancer experts design the treatments used in clinical trials.

Some possible risks include:

• Side effects may be worse than those of the standard treatment.
• Side effects may occur that the doctor does not expect.
• New treatments do not always turn out to be better than, or as good as, standard treatment.
• As with standard treatment, the new treatment may not work for you even if it works for other patients.

What are my treatment options?

Treatment options may include:

Standard treatment: There are standard treatments or “best known” treatments for most types of cancer. Standard treatments change over time as doctors learn from experience and research. In some cases, the standard treatment may be no treatment at all. For example, standard treatment may be to watch the cancer and wait to see if it grows.

Clinical trials: Many clinical trials are for new medicines or treatments that the FDA has not yet approved; however, some trials study treatments that the FDA has already approved. In these trials, doctors may look at new ways to give the treatments, or study different doses. Also, doctors may test treatments in different types of cancer.

Both standard treatment and clinical trials may involve:

• Chemotherapy
• Surgery
• Radiation
• Combined treatments (more than one kind of treatment used together)
• No treatment or delayed treatment

What is my prognosis?

Your prognosis is what may happen with your cancer and how your cancer might respond to treatment. It is important to ask your doctor about your prognosis. This may affect your choices about treatment. Ask your doctor how the both standard treatment and the clinical trial might affect your prognosis.

Who pays for the clinical trial?

All trials are different. A clinical trial’s sponsor may pay for the new treatment, extra tests and extra doctor visits needed for the trial. The clinical trial sponsor may be:

• MD Anderson
• The National Cancer Institute
• A drug company
• A non-profit organization

Your health insurance should pay for tests and doctors visits that you would need even if you were not on the trial. Please ask your patient access specialist to explain how your insurance benefits apply to clinical trials and to learn more about what you might have to pay.

Who would be in charge of my care in the clinical trial?

Your doctor and nurse will still care for you. In a clinical trial, you will also have a:

• Principal Investigator (PI): The PI is usually a doctor. He or she runs the clinical trial and makes sure that the health care team follows the plan.
• Research Nurse: The research nurse teaches patients about the trial and collects data from patients on the trial. The research nurse is a good contact if you have questions during a clinical trial.

Would there be any follow-up after the clinical trial?

Yes, you would continue to see your doctor for treatment and follow-up care.

Would I be allowed to quit the clinical trial?

All patients in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk to your doctor first. Your doctor can tell you how quitting the trial might affect your health and if there are other treatment options. Your relationship with your health care providers will not be changed by your decision.