What is a clinical research study and how does it work?
Clinical research studies, also called clinical trials, look at new ways to prevent, diagnose and treat disease.
These studies are necessary to learn whether an investigational medication is safe and useful to treat a specific disease or condition. Participation in clinical trials enables researchers to better understand the safety and effectiveness of a new investigational medication. This information is necessary to develop new treatment options for people with Crohn’s disease.
Every study is conducted according to a plan called a protocol. The protocol helps to ensure the safety of participants while also answering specific research questions. The protocol describes:
who can and cannot participate in the study
how long participants will be in the study
what is the dose and administration method of the investigational medication
what tests and assessments that participants must undergo
Every protocol is evaluated by an independent committee of people to make sure appropriate measures are in place within the protocol to protect the rights and safety of participants.
If you decide to take part in a study, the study site doctor or a member of their staff will discuss the protocol with you, and you will need to give your informed consent so that you may participate.
If you enter, you may decide to withdraw from the study at any time and for any reason.
Participating in a study means you will be carefully monitored for safety and for disease activity; the monitoring ensures your safety and proper management of the disease.
In the event of any new or unwarranted symptoms, you will have access to a 24-hour contact phone number to call.
Once the study results are available, you will be informed by your study site of the findings and which treatment group you were assigned to.
Get Involved In A Study
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