WHAT IS A CLINICAL TRIAL?

Clinical trials are carefully regulated studies sponsored by pharmaceutical and bio-technological companies and are made possible by people like you who volunteer to receive investigational treatments. Qualified physicians and other research professionals supervise clinical trials that are approved by the U.S. government's FDA as well as Institutional Review Boards. Clinical testing of a new drug is a step-by-step process that ensures you receive careful medical attention.

In a clinical drug trial the volunteer is randomly (like the flip of a coin) assigned to receive one of three kinds of medication: an investigational medication (the study drug), a medication already available on the market, or a placebo. A placebo is a harmless, inactive medicine used for comparison with the study medication. Throughout the study the volunteer returns for regular check-ups to make sure that the treatment is safe and effective.

WHY SHOULD YOU JOIN?

By volunteering in a clinical trial, you help in the development of new medical therapies that may offer better treatment, or even cures, for life-threatening and chronic diseases.  People participate in clinical trials for various reasons: to help in the advancement od science, to get medical care or in hopes of trying the latest treatment for a particular disease or condition.

It's important that you make an informed choice about volunteering for a clinical trial. Before signing an informed consent form, you must read it, understand it, ask questions about it and most importantly, feel comfortable with it. You always have the right to withdraw from the trial at any time, for any reason.

CLINICAL TRIAL PROCEDURES

After enrolling, you will receive a physical examination, a review of your medical history and a detailed description of your specific clinical trial and what's expected of you.  You should feel free to discuss your medical treatment with your regular provider at any time.

You will need to keep scheduled visits, follow medication times and doses, and honestly communicate with your physician and research professional.  Your medical records are confidential, and your privacy is protected.

POST TRIAL FOLLOW UP

After the study is done, you will return to your usual medical care. Occasionally, a pharmaceutical company might continue to provide the study medication to those who have a serious illness and are responding well.  Sometimes volunteers will stop receiving the investigational treatment and may have to wait for the drug to become available to the public.

All information from the clinical trial is collected and analyzed. This information determines whether a drug is safe and effective. FDA medical advisors and specialists review the information before approving any new drug.  Even after a drug is approved, pharmaceutical companies will continue to conduct studies that compare the new drug to other drugs on the market. Other studies might be conducted to determine if a treatment can be given to children or special populations, or to assess a drug's long-term impact on the quality of a person's life.

For more information about clinical trials, please visit www.clinicaltrial.gov