Why should I join a clinical trial?

Wanting to find a therapy that works better than current options

• Participating in clinical studies gives you a chance to try new therapies that are not yet FDA approved or commercially available.
• When your condition is not responding to available therapy or you have developed tolerance or allergy to conventional medication, clinical study medications offer additional options to control your disease.

To get more monitoring of my condition

• Patients in clinical studies are checked more closely than in typical clinical care to ensure their safety.
• Patients in clinical studies (particularly cancer studies) do better than patients who are not in clinical studies. This may be due to closer monitoring.

Wanting to contribute to progress in IBD research

• There are slightly over a million people with IBD in the United States. This is not a huge number. To make progress in IBD research, some people need to join clinical studies. Unlike more common diseases like diabetes, progress in IBD requires that many people with IBD enroll in clinical studies.

Why do people hesitate to join a clinical study?

Worried they won't get the best therapy available

Federal regulations require you to have the best therapy available PLUS any new therapy. You will not be denied effective therapy.

Worried about getting placebo

To truly test if a drug works, it must be compared to a placebo. Some patients in a randomized study will receive a placebo, in addition to their usual medicines. Most studies allow patients to cross over to the experimental drug if they don't get better. Other studies allow patients access to the experimental drug after the study ends.

Worried about committing to a study and not being able to get out

You can change your mind and get out of a study at any time. This is required by federal regulations on research.

Think about it. The only way to know if new therapies work is to give them a try.

If you are not sure if you qualify for a particular study and would like to learn more, contact the clinical research staff in the U-M Inflammatory Bowel Disease Program:

Higgins Study Coordinator Team
Tel: (734) 615-4843
E-mail: higginsSCteam@umich.edu