A clinical trial is a research study used to validate a new treatment or therapy in volunteers young and old. Through these studies, and by conducting them in controlled environments, researchers and medical professionals can determine if a treatment is safe and efficacious, and how it can be used to treat a specific disease or condition. For these reasons, clinical trials are a vital component in the advancement of medicine.
Clinical trials are conducted in different steps, or “phases.” As explained below, each phase serves a specific purpose in the treatment development process.
Phase I studies are used to determine the safety of a treatment in participants, and also study how the treatment interacts with the body. Phase I studies help create a foundation for the drug upon which future studies can build on.
Phase II studies are used to test a treatment’s effectiveness, while continuing to monitor any side effects that may occur. Once this phase is complete, researchers have a better idea about what the future of the drug will look like, how it will work, and who will be able to use it.
Phase III studies validate the effectiveness of the treatment and allow researchers to determine its safety and efficacy. In some cases, Phase III studies may take place after a treatment has been approved by the FDA.
Phase IV studies are used to test a treatment’s effectiveness in a real-world setting, after it has been made available to the public. These studies gather additional information about the treatment, including benefits, risks, and its effect on quality of life.
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