Volunteer Information

What is a Clinical Trial?

A clinical trial is a research study designed to answer specific questions about new therapies or new ways of using marketed treatments. Clinical trials are used to determine whether new medications or treatments are both safe and effective. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the effectiveness of their treatment. Coordinators are available at all times to handle questions or problems that may arise.

Three Phases of Clinical Trials

The clinical research testing of a new investigational drug is done in three phases before being ready for consideration for FDA approval.

Phase I:  These studies are primarily concerned with testing the drug’s safety in human volunteers. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to100), who are usually paid for participating in the study. About 70 percent of experimental drugs pass this initial phase of testing.

Phase II:  Once a drug has been shown to be safe, it must be tested for safety and effectiveness. This phase lasts from several months to two years. It involves up to several hundred patients. Most of these trials are randomized, i.e. the patients are randomly assigned (similar to flipping a coin) to a “control” group who will receive a standard treatment or placebo (sugar pill). They are also typically “blinded”; meaning neither the patient nor the physician knows which group the patient has been assigned to. This is done to remove any bias the patient or the physician might subconsciously develop in assisting the patients.

Phase III:  In a Phase III study, a medicine is tested in several hundred to several thousand patients. This large scale testing tries to provide the drug company with a more complete understanding of the medicines effectiveness, benefits and range of possible side effects. Once a Phase III study is successfully completed, a drug company can request FDA approval for marketing the medicine.

There are great benefits to participating in clinical trials. Your participation allows you to:

• Take an active role in your own healthcare.
• Gain access to investigational treatments that are not available to the public.
• Obtain free expert medical care at leading healthcare facilities during the trial.
• Help others by contributing to medical research.