What is a Clinical Trial?

Pharmaceutical companies conduct clinical trials, or research studies, on investigational medications to determine if the new medications provide greater benefits compared to medications currently available on the market. These investigational medications have not yet been FDA approved.

Before research studies are performed using human participants, pharmaceutical companies conduct extensive pre-clinical animal studies to decide if the investigational medications will be safe and effective in humans.

Pharmaceutical companies must then submit an Investigational New Drug Application to the FDA. The application describes the results from the animal studies, expected outcomes of the new medication, and proposals for human research. An institutional review board (IRB) must evaluate and approve the safety of each research study before it can be conducted in humans.

Research participants are highly protected by FDA regulations as well as Good Clinical Practice guidelines. Each research participant reads and signs an informed consent prior to completing any study-related procedures. The informed consent explains the purpose of the study, procedures to be performed, associated risks or benefits of the medication, and any financial compensation for participating in the study.