Frequently Asked Questions

This web page provides information about the clinical trials process and what it means for you to volunteer to participate in a clinical trial.

• Should I Join a Trial? [ answer ]
• What is a Clinical Trial?
• What Can I Expect? [ answer ]
• What Happens After the Trial? [ answer ]

What is a Clinical Trial?
A clinical trial is a carefully designed study that involves people like you who volunteer to receive investigational treatments under close supervision by a physician and other research professionals. Pharmaceutical and biotechnology companies have developed these treatments. These companies have then selected physicians, also called investigators, who are qualified to conduct clinical trials. It is through these trials that investigational drugs may show their benefits.

All clinical trials are independently reviewed by Institutional Review Boards (IRBs).

IRBs are independent committees whose job is to make sure your rights are fully protected and that you are not exposed to any unnecessary risks. IRBs also are responsible for ensuring you sign a consent form before agreeing to participate in a trial. Clinical trials usually are conducted in three phases (I, II, III). A small number of people participate in Phase I trials. Each later phase involves a larger number of people.

In a clinical trial, a volunteer is usually assigned a specific study group. Sometimes volunteers in one study group will receive an investigational treatment or study drug. Sometimes volunteers will receive a placebo or a treatment already available.

A placebo is an inactive product used as a basis of comparison for the results of the study drug. You, your physician and your research staff may not know who is receiving a placebo and who is not. In this way, volunteers in a clinical trial can be observed by the physician and research staff more fairly. Whether you receive the placebo or the investigational drug, the level of medical attention and care that your receive is the same.

What Can I Expect?