• Allows doctors and scientists to learn something new about how to treat patients
• Designed to answer a specific health question
• May test a new drug, device or treatment option
• Determines a new way to prevent, diagnose or treat a disease or illness
• Often is also called a Research or Clinical Study

• You may receive a new treatment that is not available to any other patients
• The new treatment may be safer or more effective than current options
• Doctors and Staff monitor study patients very carefully and stay with the patient at every single step of the process•
• You may be among the first to benefit from a new treatment option

The FDA requires that all medications and medical devices must go through clinical trials before being put on the market. If a new treatment proves effective and safe in a study, it may become a new standard treatment. The medicines that people take every day are all based on the results of clinical trials. Without people volunteering to participate in clinical trials, new drugs and devices would never be approved for use.

When you participate in a clinical trial, there is no guarantee that a new treatment will produce good results. Sometimes these studies show that a new product is not the best choice for patients. There may be unpleasant, serious or even life-threatening side effects that doctors do not expect. The side effects may be worse than those of the current treatments doctors use for that illness.

Once enrolled in a clinical trial, patients will received direct contact information for the appropriate staff with 24/7 access for questions or information. If you are in a study and experience any problems, the doctor and study staff will help to make sure that you receive any and all care that you need.

The risk to you depends on the treatment being studied. Some studies involve just completing a few questionnaires and have very little risk to you at all. All known risks will be fully explained to you by the research staff before you decide to participate.

• You may be required to give a little more of your time and attention than you would to a non-research treatment.
• This may include extra trips to the study site, keeping diaries, more treatments, hospital stays or even dealing with complex dosing of medicines.
• All of this will be explained to you before you make your decision to join the study.

You are protected in a clinical trial by the same ethical and legal codes that govern medical practice. In addition, clinical research is federally regulated with safeguards to protect the participants.

You have the right to informed consent. Informed consent means you must be given all the facts about a study before you decide to take part. The risks and potential benefits are thoroughly explained in the informed consent document. You must sign the document if you want to participate. This process of keeping you informed also continues throughout the study by providing new information to you as it is learned. This includes any newly discovered risks or benefits.

You have the right to change your mind and stop participating at any time. Your participation is strictly voluntary. If you choose to withdraw from a study, you will have a chance to discuss other treatments and care options with your own doctor or a doctor from the study.

You are protected by an independent committee called an IRB. The Institutional Review Board (IRB) reviews all aspects of any new clinical trial before any patients are allowed to participate. The IRB is made up of scientists, doctors, clergy, and people with no medical background from the local community. These people monitor all research involving people at their institution.

The committee ensures that a clinical trial is ethical and that the rights of study participants are protected. They make sure that the possible benefits outweigh the possible risks before they approve a trial.

• At your next Clinic or Hospital visit ask your care provider or call the Ochsner Clinical Research Department at 504.608.4707.
• ClinicalTrials.gov - Learn more about trials going on in your area or for a particular condition
• FDA.gov - Read an overview of clinical trials for consumers and patients from the Food and Drug Administration. Includes glossaries and guidelines.