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 or EC is a group that is responsible for helping to protect the rights and welfare 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 a study if I change my mind?
Participation in any clinical research study is completely voluntary, and participants may choose to leave a study at any time for any reason. If you or your child would like to leave these studies, you should discuss this with the study doctor, who will give you information about how to do this safely.
Why are these studies being done?
Although approved medications work for some, other patients may not respond to available therapies. And of those patients who do respond, many lose response over time. These clinical research studies aim to see if an investigational medication may be safe and effective for moderate to severe atopic dermatitis patients.
What should I expect from participation in one of these clinical research studies?
Before you or your child can take part in the ADvocate Studies, you or your child will first need to attend the screening visit(s) for initial tests and assessments to confirm eligibility.
After all necessary tests and assessments have been completed and eligibility has been confirmed, you or your child will enter one of the ADvocate Studies and receive either the investigational medication or a placebo (depending on the study assignment and treatment assignment). The placebo looks like the investigational medication, but it does not contain any active medicine. Researchers use a placebo to see if the investigational medication really works. Participants will be randomly assigned – like the flip of a coin – to receive the investigational medication or the placebo. If you or your child enters a study that has a placebo, neither you nor the study team will know which of the two has been assigned. Because of this, the expectations for these studies will be the same for all participants. At the end of the studies, researchers will compare participants taking the investigational medication to those taking the placebo to see if the investigational medication works better than the placebo.
Why is there a placebo?
A placebo arm helps to evaluate the effects of the investigational medication and show if the investigational medication is safer and more effective than existing medications that aren’t a part of the study. It’s needed due to the “placebo effect” – this is what happens when a patient’s condition improves even when no active medication is given.
Whether or not you or your child receives a placebo, you or your child will be monitored very closely during these studies. If there is a change in your or your child’s medical condition while participating in these studies, the study team will inform you immediately and discuss this with you.
How long will study participation last?
If eligible, you or your child will be in one of the ADvocate Studies for between 30 and 66 weeks. You may also be asked to return to the research site for extra visits at any time during the study if the study doctor decides that extra assessments are needed for safety purposes.
If eligible, you or your child may continue receiving the investigational medication in a separate long-term extension study. Or you or your child may stop participating by scheduling a safety follow-up visit approximately 12 weeks after the last dose of investigational medication.
Learn more about the ADvocate Studies.