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Clinical research trials test new treatments. Each trial is a long process that requires many steps. Every step is important so researchers can learn if a treatment is effective, safe, and how it compares to current treatments. The research process must also protect the rights and safety of patients.
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:
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.
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:
Clinical trials follow a series of steps or phases. The research goals and plans are different in each phase of a clinical trial.
Phase 1 clinical trials test new treatments. These treatments are being studied for the first time. They are known as experimental. In this phase, a small number of people get the treatment. A goal of this phase is to find out if the treatment is safe. Researchers also want to find out the best dose.
Questions answered by phase 1
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.
Questions answered by phase 2
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.
Questions answered by phase 3
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.
Questions anwered by phase 4
Reviewed: November 2023
Use these tips and questions when you meet with members of your care team to learn more about participating in clinical trials.
Clinical trials are carefully designed research studies that test experimental treatments to see if they should be part of standard medical care.
Learn more about clinical trials