What You Should Know about Clinical Research Studies
What is a clinical research study?
Clinical research studies, also called clinical trials, look at an investigational drug or medical device to see if it is safe, how it works in the human body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for study participants’ study-related care.
In most countries, the regulatory health authority, such as the Food and Drug Administration (FDA) in the United States, requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.
Clinical research studies must be reviewed by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and well-being of study participants. During clinical research studies, every study participant is regularly checked on and given study-related medical tests and exams before, during, and sometimes even after the study.
Can I leave the study if I change my mind?
Participation in any clinical research study is always completely voluntary. Taking part in this study is your choice, and you may leave the study at any time for any reason. You should consult the study doctor and staff about concerns and questions you have at any time during the study.
What should I expect if I choose to take part in this study?
Before you can take part in the NAVIGATE-1 Study, you will first need to attend the screening visit(s) for initial tests and assessments to see if you are eligible to participate. After all necessary tests and assessments have been completed, and if you are eligible to participate, all study procedures, including surgery, are covered by the sponsor.
How long will study participation last?
Participation in the study could last approximately six weeks.
Learn more about the NAVIGATE-1 Study.See If You May Qualify