A clinical study, also called a clinical trial, helps doctors determine if an investigational drug or device is safe and effective for preventing, detecting or treating a disease or disorder. The ultimate goal is to improve public health.
Clinical studies are conducted in phases, depending on their specific purpose.
In Phase I studies, doctors test an investigational drug or device for the first time to determine how it works in the human body, side effects associated with increasing doses, and early evidence of effectiveness. Phase I studies may be conducted with healthy volunteers or volunteers with specific medical conditions.
Phase II studies gather preliminary information on whether the investigational drug or device works in people who have a certain disease or condition. Safety continues to be evaluated, and short-term side effects are studied.
Phase III studies are conducted to confirm the effectiveness of the investigational drug or device, monitor side effects (short and long term), compare it to commonly used treatments, if appropriate, and collect information that will allow it to be used safely. The INTREPID study falls into the Phase III category.
In Phase IV studies, doctors seek additional information including the benefits, risks and best use of the investigational drug or device after it has been approved by health authorities.
An investigational drug or device must undergo one or more Phase III clinical studies before health authorities will consider approving it for the public.
To help ensure your safety, clinical studies are regulated by the government. To help protect your privacy, your name, address, phone number and other information that identifies you will not be shared with anyone outside of the study team unless you have provided authorization to do so.
A process called informed consent ensures you know all the facts regarding study participation and the Vercise™ system. If you volunteer to participate, you will sign an informed consent document. This document is not a contract; you may withdraw from the study at any time, for any reason, without penalty.
Sources: ClinicalTrials.gov, a service of the U.S. National Institutes of Health
U.S. Food and Drug Administration