THINGS THAT YOU SHOULD KNOW FIRST...

BACKGROUND INFORMATION FOR CLINICAL RESEARCH TRIALS

- After years of testing compounds in animals and human cells, a pharmaceutical company provides their data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in humans. This is called the Investigational New Drug Application or IND.

- Clinical testing of experimental drugs is normally done in three phases. Each phase involves a larger number of people until the FDA grants New Drug Approval (NDA). Once NDA has been granted, a pharmaceutical company conducts late phase 3 and phase 4 studies.