Clinical Trial Patient Information: What is a Clinical Study?

A clinical study is medical research that determines the safety and effectiveness of a drug or treatment and discovers any side effects. Clinical studies use humans; pre-clinical studies use animals. Clinical trial volunteers are able to participate in various kinds of studies.

The drug or treatment under study may be:

• new and not tested on people before
• an existing one being used in a new way

In some clinical studies, a new drug or treatment may be compared with the best-known standard therapy to see whether it is more effective or causes fewer side effects. Clinical trial patients enable researchers to determine the best use for these drugs and therapies.

Information from clinical studies:

• helps regulatory authorities around the world decide whether to approve a drug for use in their country
• guides health professionals in their decisions about prescribing drugs or other treatments to patients
• assists consumers with the proper use of over-the-counter and prescription medications.