The Crohn's & Colitis Foundation is outlining how clinical trials progress through four distinct phases, an effort aimed at reducing patient uncertainty and addressing enrollment shortfalls in research into inflammatory bowel disease. A study by the organization estimates that nearly 1 in 100 Americans has IBD, a term covering conditions including Crohn's disease and ulcerative colitis that inflame the gastrointestinal tract and can produce symptoms and complications elsewhere in the body.
The stakes are practical as well as scientific. According to the foundation, many clinical trials face delays due to lack of enrollment. Dr. Ruby Greywoode, a gastroenterologist at Montefiore Medical Center, said broader participation is needed, particularly among groups with high rates of chronic disease. "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," Greywoode said.
The foundation describes trials as taking many forms, from medication studies and medical tests to investigations of diet's role in disease management or the emotional impact of living with a condition such as IBD. Each trial is typically divided into four phases that build on one another but are conducted separately, and the questions answered depend on which phase a participant joins.
Phase 1, the smallest, is often conducted among healthy people without the condition to learn how the body reacts to a medication, determine safe dosage ranges and identify potential side effects. Phase 2 tests the treatment in a slightly larger group of people who have the condition, with participants randomly assigned to different treatment groups that may involve different dosages or placebos. Phase 3 expands further and lasts longer, comparing the drug against current treatment options, gathering information about how it affects different kinds of people and identifying side effects over time; at the end of this phase, the company decides whether results are strong enough to submit an application to the FDA. Phase 4 continues after approval, monitoring real-world uses and effects, sometimes following thousands of patients for several years.
For patients, the foundation stresses that participation is typically free because most trials are federally or privately funded, though costs such as travel, time off work and childcare may or may not be covered by the sponsor. Participants may withdraw at any time, and eligibility criteria vary by study, including factors such as age, gender, medical history and current health status.
The effort matters because research into IBD has the potential to change lives, including those of participants themselves. The foundation said it wants to make clinical trials less mysterious, more accessible and more representative of the people affected by these conditions. Those interested in IBD research can explore opportunities at CrohnsColitisFoundation.org or search for trials with their doctor at crohnscolitisfoundation.org/clinical-trials-community.
Greywoode framed participation as a way for patients to influence the field. "Clinical trials give patients a real way to shape the future of treatment," she said. "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."
