What is a clinical trial?
Clinical trials are research studies that test how well new medical approaches work in people. Before an experimental treatment can be tested on human subjects in a clinical trial, it must have shown benefit in laboratory testing or animal research studies. The most promising treatments are then moved into clinical trials, with the goal of identifying new ways to safely and effectively prevent, screen for, diagnose, or treat a disease.
What are the phases of clinical trials?
Clinical trials are conducted in a series of steps or phases. Each phase of a clinical trial has a different purpose.
- Phase I: Researchers test a drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, dosage range, and side effects.
- Phase II: The new drug or treatment is given to a larger group of people (100-300) to evaluate its effectiveness and further study its safety.
- Phase III: The new drug or treatment is given to large groups of people (1000 – 3000) to confirm its effectiveness, monitor side effects, compare it to similar treatments, and collect information to allow for its safe use.
If the experimental treatment works well in a Phase III trial, researchers can submit an application to the U.S. Food and Drug Administration (FDA) asking permission to make the treatment available to the public.
Why should I consider participating in a clinical trial?
People take part in clinical trials for many reasons. When you volunteer to participate in a clinical trial, you help researchers learn more about curing, preventing, and treating liver disease and its complications, as well as improve healthcare for people in the future. In addition to helping others, you get extra care and monitoring from the clinical trials staff and may receive the newest treatments for a disease.
Clinical trials are required to follow the same ethical and legal guidelines as standard medical practice to protect the safety of participants. However, before participating in a clinical study it’s important that you to talk to your healthcare provider and learn about the study’s potential risks and benefits.
If you’re thinking about participating in a clinical trial and would like more detailed information, the NIH Clinical Trials and You website is an excellent resource.