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.
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 approved 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 My Child or I Leave the Study If I Change My Mind?
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 or your child would like to leave the study, you should discuss this with the study doctor, who will give you information about how to do this safely.
What Should I Expect?
Before you or your child can take part in the Calm-CAH or Balance-CAH Study, you will first need to attend the screening visit(s) for initial tests and assessments to see if you or your child is eligible to participate.
The study team will provide you with more information about the study and answer all of your questions. They will discuss the benefits and risks as well as study support that may be available for you and your family.
After all necessary tests and assessments have been completed, and if you or your child is eligible to participate, you may enter the study and receive the assigned study treatment.
How Long Will Study Participation Last?
Participation in the Calm-CAH Study lasts about 10 months, while participation in the Balance-CAH Study may last 4 to 9 months depending on which part of the study you or your child is enrolled in. Participants may also have the option to join a long-term study after completing the Calm-CAH or Balance-CAH Study.