Phase IV Clinical Trial

A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of […] Read More

A study that tests the safety and how well a new treatment works compared with a standard treatment. In most cases, treatments move into phase III trials only after they meet the goals of phase I and II trials. Phase III clinical trials may include hundreds of people. Source: NCI Read More

A study that tests how well a new treatment works for a certain disease and compares the new treatment with a standard treatment. Phase II/III clinical trials may also provide more information about the safety and side effects of the new treatment. Combining phases II and III may allow research questions to be answered more […] Read More

A study that tests whether a new treatment works for a certain type of disease. Phase II clinical trials may also provide more information about the safety of the new treatment and how the treatment affects the body. Source: NCI Read More

A study that tests the safety, side effects, and best dose of a new treatment. Phase I/II clinical trials also test how well a certain type of disease responds to a new treatment. In the phase II part of the clinical trial, patients usually receive the highest dose of treatment that did not cause harmful […] Read More

The first step in testing a new treatment in humans. A Phase I study tests the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment and how the treatment affects the body. The dose is usually increased a little at a […] Read More

The stage of a clinical trial studying a drug or biological product, based on definitions by the FDA. The phase is based on the study’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Read More

A specific result or effect that can be measured. Source: NCI Read More

A type of study in which both the health providers and the patients are aware of the drug or treatment being given. Source: NCI Read More

The Office within the U.S. Department of Health and Human Services that protects the rights, welfare, and well-being of people involved in clinical trials. Source: NCI Read More