FAQs

A clinical research study is a medical research study in people. The potential treatment or device being studied only enters a clinical study after researchers test it in the laboratory. If it looks promising, scientists carefully test and collect data about the potential treatment through clinical studies. A clinical study helps us learn how an investigational treatment works in the body. Clinical studies must be reviewed and approved by a regulatory agency to ensure the health, privacy, and safety of study participants. In the United States, it’s the Food and Drug Administration (FDA). In Europe, it’s the European Medicines Agency (EMA). Agencies vary by region. They decide whether to approve the investigational treatment for doctors to prescribe.

The first step is discovering and developing an investigational medicine to study. After that, clinical studies show if it is safe and effective and provide information on any side effects. Sometimes, researchers compare the potential medicine to a placebo. The placebo looks and is administered like a potential treatment but has no active ingredients. The potential treatment may also be compared to a standard treatment already approved and used for treatment. They compare it to current treatments, if available, to find out if the potential treatment is better.