Clinical trial programs are designed to study the safety and effectiveness of a new drug or treatment. This is a long, and rigorous process with multiple steps or phases. 

• Phase l: Safety: A new treatment is studied in a small number of people for the first time. The goal is to understand the safety of the treatment, study different doses of the treatment, and identify potential side effects.
• Phase ll: Efficacy: The treatment is now studied in a larger number of people to ensure it works. Safety, side effects, and ideal dosing are also studied.
• Phase lll: Potential approval: These are typically two large trials, intended to prove that the treatment is both safe and effective across hundreds or thousands of patients. The treatment is compared to existing treatments for the selected condition, and must prove to be at least as safe and effective as the existing treatment. If successful, the Food and Drug Administration (FDA) reviews the entire clinical trial program and determines if it is appropriate for approval.
• Phase IV: Additional information: Also called “post-marketing studies”, these trials occur after the therapy has been approved by the FDA. They may look at specific groups of patients, different conditions, long term outcomes, and more. 

1. How do I participate in a clinical trial?
   Click here to start the process. Please review the list of trials above. Each has a set of criteria to determine who may participate. 
2. How do I understand potential risks, benefits, and my responsibilities?
   Before starting the trial, you will be given an informed consent form outlining the details of the research study. This form includes information on why the study is being conducted, how long it will last, testing you may need to undergo, contact information, possible risks and benefits. All clinical studies follow rigorous FDA rules.
3. Is there a possibility I will receive a placebo?
   Some trials compare the study drug to placebo. Others compare study drug to a treatment that is already approved to treat a condition. These details will be discussed specifically with each trial. Often if you start in a placebo group, or “control” group, you may change to the “study drug” under certain conditions. 
4. What if I decide I don’t want to be part of the study?
   That is ok. It is always your decision. This should be discussed with your physician to ensure you are both able to have a complete conversation and make a fully informed decision. 
5. What else should I know?
   Taking part in clinical research trials is a personal decision. Each patient and trial should be evaluated on an individual basis. Discussion with your doctor, in addition to the informed consent process, should ensure that you are comfortable with the potential benefits and potential risks prior to making your decision.