Steps of a Clinical Trial

In the United States, an Institutional Review Board (IRB) must approve each clinical trial plan before it can start. An IRB is a committee that includes medical experts, scientists, and doctors. The committee carefully considers each new clinical trial before it begins. The IRB approves each trial based on its potential benefits and risks. This helps protect patients’ health and rights.

A clinical trial can only include certain patients. The research team screens patients to see if they meet the trial’s requirements or criteria. This is known as eligibility criteria or inclusion criteria. The criteria are different for each clinical trial. They may include:

• Type or stage of disease
• Patient age
• Health conditions

Patient screening helps protect patients’ health and safety. The clinical trial only includes people who are most likely to benefit in a safe way. This also helps scientists learn about how the treatment works on certain types of patients.

It is your decision if you want to take part in a clinical trial. You are not required to take part.

A member of the research team will tell you about the clinical trial and what to expect. If you agree to take part after learning about the trial, you give informed consent. If the participant is not an adult or not able to give consent, a parent or legal guardian can give written consent.

Children’s consent

The research team may ask children to sign a form agreeing to take part in the clinical trial. A member of the research team will explain the clinical trial so that the child and family understand and know what to expect. Children under age 7 are not usually asked for consent. The informed consent process should give enough details to decide whether to take part.

After the informed consent process, participants should know the following:

• The purpose of the research
• Who can take part
• Treatments and how often treatments occur
• How treatments are given
• Tests and procedures that are done and how often
• Risks of treatment and procedures and how they are monitored
• Available treatments outside of the clinical trial
• How the research team will communicate with patients
• How details are shared with others or kept confidential
• Who to contact about questions or concerns

Phase 2 trials test the treatment in more people for a longer time. The goal is to find out if it works for people with a certain disease or condition. The research team monitors side effects.

Phase 3 trials test the treatment in a large group of people. The research team may compare this treatment against a “standard” treatment. Standard treatment is a widely used treatment. Or the research team may compare 2 different experimental treatments. The care team monitors side effects over a longer time.

Phase 4 trials happen after the treatment has been approved by the U.S. Food and Drug Administration (FDA). This phase tests the treatment in a large number of people. Researchers collect details about how the treatments are used. They also monitor side effects and effectiveness of the treatment over long time periods in many people.