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.