Clinical trials are carefully designed research studies that evaluate investigational medicines for all kinds of diseases. The study design is described in a document called the “study protocol.” The study protocol describes what types of people may join the study. It also lays out a plan for the schedules of appointments and tests that the study volunteers receive. The purpose of clinical studies is to determine whether a new investigational medicine is safe and effective for use in patients.

Before doctors are allowed to give new medicines to patients, the medicines must be proven to be both safe and effective. The company that is researching the medicine must prove that it is safe and effective to the U. S. Food and Drug Administration (FDA) by conducting clinical trials. An investigational medicine goes through three phases of clinical trials. In each phase, volunteers are given study medication under the supervision of a doctor:

• Phase 1 - testing in a small group of people (20 - 100) to test a drug's safety, dosage, and potential side effects. The people in this phase are usually healthy.
• Phase 2 - testing in 100 - 500 people to further evaluate a drug's safety and effectiveness. The people in this phase usually have the disease or condition for which the drug is being studied.
• Phase 3 - testing in 1,000 - 10,000 people to confirm a drug's effectiveness, monitor side effects, and compare it to other approved medicines. The people in this phase have the disease or condition for which the drug is being studied.

People who volunteer to participate in a clinical trial have different reasons for their decision. Some of the more common reasons are:

• To advance science so that new 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.

Some of the reasons people decide not to participate are:

• They do not want to take an investigational drug or no drug at all (placebo or sugar pill).
• They have concerns because not very much is known about the drug.
• They are concerned that they may have a side effect from taking the drug.

Clinical trials may provide benefits, but there are risks as well. 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 purpose of the Informed Consent process is to give you the information you need to decide whether or not to participate in a clinical trial.

The first part of the Informed Consent process is an Informed Consent Form, which is a document that describes important aspects of the clinical trial. You will be asked to read the Informed Consent Form and ask any questions you might have. If you decide to participate in the clinical trial, you will be asked to sign the Informed Consent Form before you start the trial.

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