What Are Clinical Trials?

Clinical trials are closely monitored studies of new treatments for cancer patients. Nearly all the cancer treatments and medications used today began with clinical trials. Clinical trials help find better ways to prevent, diagnose, or treat a disease.

The most common clinical trials evaluate new drugs, medical devices, biologics, or other treatments in strictly controlled studies. The U.S. Food and Drug Administration must approve new therapies before they can be widely used. When a new treatment looks promising, researchers at UNC begin a new clinical trial.

• This research helps scientists improve IBD therapies and work toward finding a cure.
• Scientists study clinical trial treatments to determine if they will be more effective or produce fewer side effects than current therapies.
• Scientists study whether clinical trial treatments will expand treatment options for IBD patients.

Because clinical trials are experimental, they have risks as well as benefits. Risks depend on the treatment being studied and the health of the person in the study. A health-care provider will discuss potential risks and side effects before trial enrollment. You will have opportunities to ask questions, and will be given as much time as you need to decide if you would like to enroll.

Benefits may include the following:

• Playing a more active role in one’s own health care
• Gaining access to new research treatments before they are widely available
• Obtaining expert medical care at leading health care facilities during the trial
• Helping other patients by contributing to medical research
• Helping scientists find new and better IBD treatments

Risks may include the following:

• Unpleasant side effects
• Serious side effects
• Unknown health risks
• Flare of your disease from ineffective or no treatment

Patients in clinical trials are closely monitored and may be seen more often by health-care providers and receive feedback on their condition more frequently.