ABOUT CLINICAL TRIALS

What is a clinical research trial?

Clinical trials are research studies that test new treatments to prevent or treat disease, symptoms of diseases or the side effects of other treatments.

Clinical trials may test new ways of using an existing drug.  For example, there may be a question of whether a higher dosage may help more than the current prescribed dose or if two drugs work better in combination.  A clinical trial may also be for a new drug to treat a disease.

The Food and Drug Administration requires that a company perform clinical trials to demonstrate the new treatment is safe and effective.

What you can expect:

 If you choose to participate in a clinical trial:

• A member of the study staff will ask you questions or review your medical information to see if the study is an appropriate match for you.

• If you are eligible to participate you will be given a consent form that explains the trial and what you will have to do.

• You will under go a physical exam and medical tests as necessary.

• You will be medically monitored on a regular schedule.  If at any time you do not respond well or get worse, the physician will stop the study and you will receive treatment.

What are your rights?

 You have the right to:

• Informed consent – this means all information about the study will be explained to you before you agree to participate.

• Leave a clinical trial at any time for any reason.

• Some of the medical information that is collected during the trial, such as medical tests.

• Know what other healthcare options are available if you choose not to participate in a clinical trial.