What are Clinical Trials?

A clinical trial is a research study involving human volunteers and is aimed at answering specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work and new ways to improve health.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs and dosages, the length of the study, and the outcomes that will be measured. Each person participating in the study must agree to the rules set by the protocol.

Why are trials conducted?

Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the "standard treatments." Sometimes clinical trials study different ways to use the standard treatments so they will be more effective, easier to use and/or have fewer side effects. Sometimes studies are done to learn how to best use a treatment in a different population for whom the treatment was not previously tested.

What are some possible benefits to my participation?

Participants in clinical trials:

• Gain access to potential new treatments.
• Receive expert medical care for the condition being studied. Investigators are often specialists in the disease being studied.
• Help others by contributing to medical research and treatment advances.

What are some of the possible risks of my participation?

• There may be unpleasant or serious side effects resulting from the treatment.
• The treatment may not be effective.
• Participation in the trial may be demanding and time consuming.

Patient Protections

To protect the rights and welfare of clinical research participants, U.S. federal government agencies, including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), oversee much of the clinical research done in this country.

In addition, there are committees known as Institutional Review Boards (IRBs) that oversee the centers where clinical research studies are conducted. IRBs review and approve study protocols to ensure that a clinical trial is ethical and that the volunteers' rights are protected. A participant in a clinical trial has access to the IRB that is overseeing the research and access to the physician and staff conducting the trial.

If you are interested in a clinical trial, please fill out our sign-up form.