A clinical trial is a research study designed to provide valuable data for a new or existing treatment, or treatment method, to determine if it is safe and effective for humans. In order to determine if a treatment is both safe and effective, testing must be conducted to provide statistical proof. According to laws and regulations, all clinical trials must be reviewed, approved and monitored by an Institutional Review Board (IRB) to ensure the ethical treatment of participants, and to ensure that all participants are fully informed about the study prior to agreeing to participate.