Frequently Asked Questions (FAQs)

Before enrolling in IGNITE, you may have questions regarding clinical research studies, the length of the study, and if you may leave the study at any time. If you end up qualifying for the study, you may ask questions to the study team at any time during your involvement in this study.

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 body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care. Without clinical trials and volunteer study participants, there would be no new medications.

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. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.

Can I Leave the Study?

Participation in any clinical research study is completely voluntary, and participants may choose to leave the study at any time for any reason. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely.

What Are the Steps Before I Join?

Before you can take part in the IGNITE clinical research 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, you may enter the study and receive the study drug.

Questions to ask your doctor