Do you have questions about the study?

What is a clinical research study?

A clinical research study is a research project done with human volunteers to learn more about an investigational medication or treatment. In a clinical research study, the participants are under the supervision of a doctor and other research professionals. In regards to the EXPLORER study, the word "investigational" means the 3 drugs (vedolizumab, adalimumab, and oral methotrexate)—although all three have been individually approved by the US Food and Drug Administration (FDA)—have not been approved for use in combination to treat CD.

Why is clinical research important?

By volunteering, people help doctors find new treatments and ways to provide care. As a study goes on, the doctor and researchers gather information, to see whether the investigational medication or treatment:
  • Improves the patient’s condition
  • Offers no benefit to patients
  • Causes patients unexpected harm
All of these results are important because they advance medical knowledge about the disease and treatments and help improve patient care.

What happens after a clinical research study?

After a clinical research study is finished, all of the information is collected and analyzed to help determine the safety and effectiveness of the medication or treatment. Your doctor or healthcare provider can help determine the best treatment options after you complete a clinical research study.

How will I be protected if I participate?

Clinical research studies are regulated, following rules set by government health authorities. The clinical research study will follow a protocol, which is a detailed study plan. Each clinical research study must also be reviewed by an institutional review board (IRB) or ethics committee (EC). IRBs and ECs are groups of people who help protect the rights and welfare of people participating in research studies. IRBs and ECs are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people. Your privacy will also be protected. The research team cannot tell anyone that you are participating in a clinical research study without your permission. All of the information collected during the study will be kept confidential, and your name won’t be listed in any reports based on the study.

Why should I consider participating in this study?

By participating in the EXPLORER clinical research study, you can help advance the understanding of Crohn’s disease. The information gathered (including blood sampling, endoscopies, biopsies, diaries, and the other tests completed) might help develop new ways to monitor and treat CD.
Participating in the study also allows you to proactively monitor your digestive health and receive study-related medical care from a team of specialists. Those who qualify for this study will receive study medications and study-related medical care at no cost to them.

What should I know before participating in this study?

Like all research studies, there is a certain amount of risk. The study doctor will speak to you about any possible side effects that you might experience during the study. Since this triple combination drug therapy will be under investigation, there may also be side effects that we don’t already know about, which can happen when the study medication(s) are given in combination or as monotherapy. It is important that you report any symptoms or health problems to the study doctor, whether or not you think these problems are related to the study medication(s).

Can I leave a clinical research study after it has begun?

Yes, your involvement is completely voluntary, and you have the right to leave a clinical research study at any time. When you want to leave, tell the doctor or research team. It’s also helpful to explain your reasons for leaving.
For more information about clinical trials, visit
http://www.ccfa.org/research/participate-in-research/