Nearly 1 in 100 Americans lives with inflammatory bowel disease (IBD), a group of conditions including Crohn’s disease and ulcerative colitis that cause inflammation of the intestines, according to a study by the Crohn’s & Colitis Foundation. The foundation is working to make clinical trials less mysterious and more accessible, especially as many studies face delays due to lack of enrollment.
Clinical trials can take many forms, including medication studies, medical tests, investigations into diet, or examinations of the emotional impact of living with a condition. Each trial is typically divided into four phases that build on one another. Phase 1 asks whether a drug is safe, often testing it in a small group of healthy people to determine safe dosage ranges and identify side effects. Phase 2 asks whether the drug is effective, testing it in a slightly larger group of people who have the condition. For instance, a phase 2 IBD trial might give the drug to 100 people with IBD to see whether it works or causes short-term side effects. Participants are randomly assigned to different treatment groups, which may involve different dosages or placebos.
Phase 3 asks whether the drug works better than currently available treatments. This phase lasts longer and involves more participants as researchers gather information about how the drug affects different kinds of people, whether it is better than standard treatments or placebos, and what side effects may arise over a longer period. At the end of this phase, the company decides whether the results are strong enough to submit an application to the FDA, which will review and potentially approve the treatment. Phase 4 monitors the drug’s real-world use and effects after approval, sometimes following thousands of patients for several years.
“We need more people to get involved in clinical trials, especially those from underrepresented communities, including people of color and older adults, who have some of the highest rates of chronic disease,” said Dr. Ruby Greywoode, a gastroenterologist at Montefiore Medical Center. She added that clinical trials give patients a real way to shape the future of treatment. “It’s not just about their own care; it can help others, too. Talking openly with your doctor can help you feel more confident about getting involved.”
For the millions of Americans living with IBD, clinical trials offer hope for more treatments, less pain and healthier lives. The foundation encourages patients to talk to their healthcare professionals about whether a trial is right for them and to explore IBD research opportunities at CrohnsColitisFoundation.org. Patients and doctors can also search for opportunities at crohnscolitisfoundation.org/clinical-trials-community. The announcement matters because participation in clinical trials is essential to developing new treatments for IBD, and broader representation can help ensure that therapies work for the people who need them most.
