Not all clinical trials are right for everyone. A trial may be safe for one patient, but not for another. Each clinical trial has a protocol that contains a strict set of rules that medical professionals must follow to decide who may join a clinical research study. These rules are called eligibility criteria. Eligibility criteria include information about:
- Age and gender
- Results of medical tests
- Medicines that you are taking
- Any other health problems
- And more
If you meet the criteria for 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 procedures you will be possibly subjected to and the risks and benefits of the study. The doctor, a research nurse, or a Clinical Research Coordinator (CRC) will review the informed consent form in detail with you. This is a great time to ask questions.
It is OK to take time to make your decision. If you like, you may take the informed consent form home with you to review before signing it. If you decide to join the clinical trial, you will be asked to sign the informed consent form and you will receive a signed copy for your records.
Some questions to ask when going through the informed consent process:
Questions about the Treatment Being Tested
- What is the reason for the clinical trial (what do 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?
- What are the possible risks and benefits (based on what is known so far)?
- What are other treatments that may be options?
Questions about Tests and Travel
- What types of tests do I have to get?
- How often do I need these tests?
- Where do I have to go to get these tests?
- How often do I need to meet with the doctor?
Questions about Costs
- Who pays for the costs of the clinical trial?
- If the clinical trial causes me to need more medical care, who pays for those costs?
- How is my privacy protected?
- Who do I call if I have more questions?
Questions about Care
- Who would be in charge of my care in the clinical trial?
Your current doctor and nurse will still be your primary care providers. In addition to the services you receive from them, when participating in a clinical trial, you will also have a:
- Principal Investigator (PI): PIs run the clinical trial and make sure that the health care team follows the protocol (the clinical research plan).
- Clinical Research Coordinator (CRC): The research coordinator teaches patients about the trial and collects data from patients in the trial. The research coordinator is your primary contact for questions you may have about a clinical trial you are participating in.
Can I stop participating in a clinical trial after starting?
Yes, you can choose to stop participating in a clinical trial at any time, but talk to your doctor first. Your doctor can tell you how doing so 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. All patients in clinical trials are volunteers.
Other things to know
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.