Am I Able to Take Part?
Not all clinical trials are right for all patients. A trial may be safe for one patient to join, but not safe for another. Each protocol has strict rules that doctors must follow to decide who may join the clinical trial. These rules are called eligibility criteria. This protects patients from getting treatment that may harm them. Eligibility criteria include information about:
You and your overall health:
- Age and gender
- Results of medical tests
- Medicines that you are taking
- Any other health problems
Your medical condition:
- Condition type and stage (if applicable)
- Other treatments you may have had
- How long it has been since you were last treated
If you have found a clinical trial that you think you want to join, talk to your doctor to see if you are eligible to take part.
How do I Sign up?
If your doctor offers you a clinical trial, you will first go through a process called informed consent. The goal of informed consent is to make sure you understand the clinical trial’s plan. The doctor or research nurse will review the informed consent form in detail with you. This form explains the clinical trial’s purpose, plan, risks and benefits.
This is a great time to ask questions. Try to bring a family member or friend to help you ask questions and write down answers. You may also want to bring a tape recorder so that later you can listen to what the doctor said. If you decide to join the clinical trial, you will be asked to sign the informed consent form. The doctor will also sign the form, and you will receive a copy.
Take time to make your decision. If you like, you may take the informed consent form home with you to review before signing it.
What should I look for on the informed consent form?
Look for the following information on your informed consent form:
- The reason for the clinical trial (what the doctors hope to learn)
- Who is eligible to take part in the clinical trial
- What is known about the type of treatment being studied
- Possible risks and benefits (based on what is known so far)
- Other treatments that may be options
- Types of tests
- How often you would need tests and meet with the doctor
- 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
- A statement about conflicts of interest (any direct financial benefit to Phoenix Children’s Hospital or your doctor from the sponsor of the trial)
- A statement about how your privacy is protected
- Who to call if you have more questions
The informed consent process does not end once you sign the informed consent form. For example, your doctor must tell you if new risks or side effects of the treatment are found during the trial. Also, please be sure to ask any questions you may have at any time 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.
Would There be any Follow-up After the Clinical Trial?
Yes, you would continue to see your doctor for treatment and follow-up care.
Am I Able to Take Part?
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.