Clinical trials are carefully designed research studies that evaluate investigational treatments for all kinds of diseases. Every clinical trial has a protocol, a set of rules and guidelines that all study doctors follow.

The protocol describes:

• what types of patients may take part in the research study
• schedules of tests and procedures
• investigational drugs and dosages
• the length of the study.

New investigational drugs require approval by the United States Food and Drug Administration (FDA). The purpose of clinical studies is to determine whether the drug is safe and effective.

An investigational drug goes through three phases of research studies. The volunteers are given study drug under the supervision of a study doctor.

• Phase 1 - testing in a small group of people to determine an investigational drug's safety, dosage and possible side effects.
• Phase 2 - testing in a larger group of people to further determine an investigational drug's safety and how well it works.
• Phase 3 - testing in more people to confirm an investigational drug's usefulness, watch for side effects and possibly compare it to other approved medicine.

People who volunteer for a clinical study have many different reasons for their decision. Some of the more common reasons are:

• To advance science so that better medicines are available to help other people.
• To have access to potential investigational treatment approaches for their condition.
• To access regular medical care related to their condition.

• I may be receiving an investigational drug or no drug at all (placebo).
• Not very much is known about the drug.
• I may suffer adverse experiences.

Clinical trials may have the potential to benefit you or hurt you. It is important to talk both to the study doctor and to your regular doctor about the potential benefits and the potential risks of being in a specific clinical study. Discussing these benefits and risks with the study doctor is part of the 'Informed Consent' process. The study doctor will ask you to read the informed consent, ask if you have any questions, and ask you to sign it if you decide to participate before you start the trial.

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