This video is a general overview of clinical research.

     

For more information on clinical studies please visit these sites:

National Institutes of Health

Introduction to Clinical Trials

Phase I-IV Trial Participation

ClinSite specializes in Phase II-IV clinical research trials

Phase I

Involves a small group (25-75) of healthy volunteers and looks at how an investigational new drug affects the healthy volunteers. The main purpose of this Phase is to evaluate and collect drug safety data

Phase II

Involves larger groups (100-500) of volunteers and the main purpose is to evaluate the effectiveness of the investigational drug in treating a particular condition.

Phase III

Involves much larger groups (1000-5000) of volunteers. In this phase data is collected on efficacy and safety while comparing to treatments already available.

Phase IV

Involves very large groups of volunteers. In this phase the drug may be FDA approved and further data is collected on efficacy and long-term safety usage is evaluated. This phase may also invovle comparisons to other commonly used treatments.