Depending on your unique health care needs, a clinical trial may not always be the best option. Every trial is different and while a trial may be safe for one patient to join, it may not be safe for another. The protocol of each trial dictates the rules, called eligibility criteria that doctors must follow to decide who may join the clinical trial. This protects patients from getting treatment that may potentially cause harm. Eligibility criteria includes information about:

You and your current health status:

• Age and gender
• Results of medical tests
• Medicines that you are taking
• Any other health problems

Your cancer:

• Type and stage
• Treatments you may have already had
• Time since your last treatment

What is informed consent?

Before you join a trial, you’ll go through a process called informed consent. Its purpose is to make sure you understand the plan for the clinical trial, including the trial’s purpose, plan, risks and benefits.

Try to bring a family member or friend to help you ask questions and write down answers. Or record the session so you can listen back later. If you decide to join the clinical trial, you and your doctor will sign an informed consent form and you will receive a copy for your records. If you prefer, you may take the informed consent form home with you to review it before signing.

What type of information is on the consent form?

The form includes information about:

Treatment

• The purpose of the clinical trial (what the doctors hope to learn)
• Who is eligible to participate
• What is currently known about the type of treatment being studied
• Possible risks and benefits (based on what is known so far)
• Other treatment options

Tests

• Types of tests
• How often you would need tests and meet with the doctor

Costs

• Who pays for the costs of the clinical trial
• If the clinical trial causes you to need more medical care, who pays for those costs

Other

• Confirmation about what phase the trial is in
• A statement about conflicts of interest (any direct financial benefit to Banner MD Anderson or your doctor from the sponsor of the trial)
• A statement about how your privacy is protected
• Organizations associated with the clinical trial (FDA, etc.)
• Who to contact if you have additional questions

Even after you sign the informed consent form your doctor must tell you if new risks or side effects of the treatment are found at any time. You should also continue to ask any questions you may have during the trial.

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.

Yes, you’ll continue to see your doctor after the trial for any further treatment and follow-up care.

What if I need to quit the clinical trial? 

All patients in clinical trials are volunteers. You may 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.

View a list of current clinical trials:

• Banner MD Anderson Cancer Center (Arizona and Colorado)
• University of Arizona Cancer Center (Tucson, Arizona)