What You Should Know about Clinical Research Studies

What Is a Clinical Research Study?

Clinical research studies, also called clinical trials, look at a study 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 study drugs and certain medical devices.

Clinical research studies must be reviewed by an institutional review board (IRB), research ethics board (REB), or ethics committee (EC). An IRB/REB/EC is a group that is responsible for helping to protect the rights and wellbeing of study participants. In addition, every research study participant is monitored with research study–related medical tests and exams before, during, and sometimes even after the research study.

See who may qualify

Can I Leave the Research Study If I Change My Mind?

Participation in any clinical research study is completely voluntary, and participants may choose to leave the research study at any time for any reason. If a participant would like to leave the research study, this decision should be discussed with the study doctor, who will provide information about how to do this safely.

What Should I Expect?

Before taking part in the Kinect-DCP Study, all potential participants will first need to attend the screening visit(s) for initial tests and assessments to determine their eligibility to participate. After all necessary tests and assessments have been completed, and if they are eligible to participate, they may begin the study and receive the study drug or placebo.

How Long Will Study Participation Last?

Participation in the Kinect-DCP Study lasts approximately 56 weeks.

Learn more about the Kinect-DCP Study.