Clinical trials are an important step in discovering new treatments and ways to detect, diagnose, or reduce the risk for disease. They reveal what works—or doesn’t—and helps the medical community weigh the benefits, risks, and side effects of potential new treatment options. Clinical trials facilitate the process of bringing new drugs and therapies to the people who need them.

A clinical trial is a biomedical or health-related study. Clinical trials are often interventional, which means that subjects are given a treatment, usually a new drug, and researchers measure the outcomes.

Over the years, researchers have developed many drugs that help people with Crohn’s disease. Perhaps you or someone you know has participated in a clinical trial.

How do clinical trials work?

The FDA (Food & Drug Administration) must approve clinical trials for new drugs. If approved, then researchers follow a protocol, or a plan of action, to conduct the trial. Usually there are multiple protocols for any given study, which might include dosage, frequency, duration, or how the results are measured.

Participants are randomly selected and assigned to a study based on certain pre-defined criteria. The gold standard for medical research is called the double-blind study. Neither patients nor the researchers know who receives which treatments until the study concludes. The benefit of double-blind studies is that they remove all potential biases so researchers can measure the true effects of the drug.

Clinical Trials for Crohn’s Disease

Humira (Adalimumab is the generic)
Initial trials of the drug Adalimumab have shown that it is effective in inducing and maintaining remission in Crohn’s patients with luminal and perianal fistulizing. A lumin is the inner open space or cavity of a tubular organ, such as the intestine, and a fistula is an abnormal opening between two internal organs or between an internal organ and the skin. Adalimumab blocks the inflammatory effects of tumor necrosis factor alpha (TNF alpha) in several inflammatory diseases, including Crohn's. TNF is a protein our body produces when there is inflammation. It also promotes inflammation.

In one study of Adalimumab, 25 percent of patients with luminal disease went into complete remission and 50 percent experienced partial remission. After one year, this response was maintained in 72 percent of the patients. By 48 months, 36 percent of patients were still in remission.

In a similar study, 17 percent of participants went into remission and 67 percent had a partial response. All the patients maintained remission or response over time.

Infiximab

In clinical trials, Infiximab has proven to be “effective and superior” to conventional drug therapies for Crohn’s disease, even in patients with fistulas who have not responded to other treatments. Inflimab is a biologic, a class of drugs that are based on compounds made by living cells. In biological therapy (also called immunotherapy or biotherapy), biologics stimulate or restore the immune system’s ability to fight disease and inflammation. Like Adalimumab, Infiximab targets TNF alpha.

Clinical Trials in Alternative Medicine

The National Center for Complimentary and Alternative Medicine (NCCAM) also sponsors clinical trials. The NCCAM recently conducted pilot studies to observe the effectiveness of dietary approaches in patients with Crohn’s disease. One trial looked at the effectiveness of probiotics, non-digestible food ingredients that selectively stimulate the growth or activity of beneficial microorganisms that already live in the colon. The other study looked at the effects of a special diet in combination with other CAM recommendations. In these pilot studies, the results were acceptable and well tolerated. Two-thirds of the participants experienced some improvement.

Should you Participate in a Clinical Trial?

There are good reasons for participating, but they are not appropriate for everyone. Being a subject in a clinical trial is a way for patients to play an active role in their own health care and in some cases, gives them access to new treatment options before they become widely available. Since clinical trials are an important step in the discovery of new treatments, your participation contributes to medical research. If you are interested, discuss this with your physician. He or she can help you determine if you are a good candidate and for which study.