Phase III (Clinical Trial)

By the time a phase 3 clinical trial begins, the experimental treatment has shown to be safe and effective. The goal of a phase 3 clinical trial is to show that the experimental treatment is better than what is already used on the open market. During the trial, doctors do not yet know which treatment is better. Therefore, this research study usually separates participants into two groups of people. One group will receive the standard treatment while the other group will receive the experimental treatment. Then, both the researchers and the participants are blinded. This type of study is called a double-blind study, and it is important for making sure the results can be trusted. That way, no single person can manipulate the results of the study. If the new treatment is shown to be safe, effective, and more effective than currently accepted treatments, then the drug may be approved by the FDA.