What are clinical research trials?

• A clinical research trial is a research study that involves human volunteers in order to answer specific health questions.  Carefully conducted clinical trials are the safest and fastest way to find effective treatments and new ways to improve people's 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, dosages, and length of study, as well as the outcomes that will be measured.  Each person participating in the study must agree to the rules set by the protocol.

Why are clinical 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.  For example, some compare existing treatments to determine which treatment is more effective.

• The current, approved treatments are called the standard treatments.  Sometimes clinical trials are used to study different ways to use the standard treatments so that they will be more effective, easier to use, and/or decrease side effects.

• Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

What are some of the possible benefits of my participation?

• Gain access to potential new research treatments.

• Receive expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied.

• Receive medications at no cost.

• Help others by contributing to medical research and treatment advances.

What are some of the possible risks of my participation?

• Depending on the study, there may be unpleasant, serious, or even life-threatening side effects resulting from the treatment.

• The treatment may not be effective.

• Participating in some trials may be demanding and time consuming.

What are some of the questions I should ask before participating in a clinical trial?

• What is the main purpose of this study?

• Does the study involve a placebo or a treatment that is already on the market?

• How will the treatment be given to me?

• How long is the study going to last and what will I be asked to do as a participant?

• What has been learned about the study treatment and are any study results published?

• Do I have to pay for any part of the study?  Will my insurance cover these costs?

• Will I be able to see my own doctor?

• If the treatment works for me, can I keep using it after the study?

• Can anyone find out that I am participating in the clinical trial?

• Will I receive any follow-up care after the study has ended?

• What will happen to my medical care if I stop participating in the study?

• Ask yourself -- Am I comfortable with the doctor and the study staff, since they will be my medical care providers during the study?