Research, trials, and evidence
Clinical Trials 101
Last Updated Nov 11, 2025
Clinical trials test new ways to prevent, diagnose, or treat inflammatory bowel disease. They follow careful rules to protect participants and to produce trustworthy results. This article explains trial phases, how studies are designed, what participation involves, and how safety is monitored. It also lists practical questions to ask and places to find IBD trials that match a person’s situation.
Phases progress from small safety studies to large effectiveness studies, then long‑term monitoring.
Oversight includes informed consent, institutional review boards, and independent safety monitoring.
Many IBD trials compare a new therapy to placebo or an active drug, often with rescue plans.
Participation is voluntary, and withdrawal is allowed at any time without penalty.
Costs vary. Sponsors usually cover study‑specific care, while routine care may use insurance.
How clinical trials work
A clinical trial is a structured study in people. Researchers ask a clear question, define who can join, and measure outcomes that matter. In IBD, common outcomes include clinical remission, endoscopic healing, steroid‑free remission, and biomarker improvement, such as fecal calprotectin and C‑reactive protein.
Most interventional trials register on ClinicalTrials.gov, which improves transparency. In the United States, rules from the Food and Drug Administration and Good Clinical Practice standards guide study conduct and safety.
Trial phases at a glance
Trials typically progress in steps. Early phases focus on safety and dosing. Later phases test how well a therapy works in larger groups. After approval, research continues to monitor long‑term safety and real‑world use.
Phase | Main purpose | Typical size | Key questions |
|---|---|---|---|
Phase 1 | Safety and dose range | Dozens | How does the drug behave in the body, and what doses are tolerable? |
Phase 2 | Early effectiveness and safety | Hundreds | Does it show signs of benefit, and what is the right dose? |
Phase 3 | Confirm effectiveness and monitor risks | Hundreds to thousands | Is it better than placebo or standard treatment, and is it safe enough? |
Phase 4 | Post‑approval monitoring | Large, real‑world | How does it perform in broad use, and are there rare risks? |
Open‑label extension studies sometimes follow Phase 2 or 3. These allow continued access and collect longer safety data.
Study designs often used in IBD
Randomized, controlled trials: participants are assigned by chance to treatment groups.
Blinded trials: participants and often study teams do not know group assignment, which reduces bias.
Placebo‑controlled trials: compare against a look‑alike inactive treatment. In IBD, rescue therapy plans are commonly built in if symptoms worsen.
Active‑comparator trials: compare a new drug to an approved therapy.
Adaptive designs: allow planned changes, such as dropping an ineffective dose, based on interim data.
Who can join
Each study lists inclusion and exclusion criteria. These often specify IBD type, disease severity, age, prior treatments, recent infections, pregnancy status, and lab results. Criteria aim to protect participants and to match the study question. Screening visits confirm eligibility with exams, labs, and sometimes endoscopy or imaging.
Safety and participant rights
Ethics committees, called institutional review boards, review the protocol before any participant enrolls. Many trials also use an independent data and safety monitoring board that reviews safety data at set times. Participants must receive informed consent materials that explain purpose, risks, benefits, alternatives, privacy protections, and costs. Participation is voluntary. A person can stop at any time, and leaving a trial does not affect regular medical care.
What participation involves
Time commitments vary by study and phase.
Visit schedule: screening, baseline, frequent early visits, then spaced follow‑up.
Procedures: symptom diaries, blood and stool tests, drug dosing, and sometimes colonoscopy or imaging.
Adherence: taking study medication as directed and reporting side effects promptly.
Remote elements: some trials use home labs, electronic diaries, or telehealth to reduce visits.
Study teams track side effects and adjust care if needed. Serious or unexpected events are reported to oversight bodies.
Placebo and rescue therapy
Placebo use is common when no proven therapy exists for the exact situation being studied. In IBD, many placebo‑controlled trials include predefined rescue options, such as switching to open‑label drug or starting standard treatment, if objective worsening occurs. Some studies use active comparators to avoid placebo entirely.
Costs, coverage, and payment
Sponsors usually pay for the study drug and study‑specific tests. Routine care that would occur anyway may be billed to insurance. Travel help or modest stipends may be offered to offset time and costs. The consent form should explain what is covered, what is not, and whom to contact with billing questions.
Access after the trial
After the main study ends, several paths exist. Some trials offer an open‑label extension. If a drug gains approval, standard insurance processes apply. When appropriate, expanded access or compassionate use may be possible for serious conditions, subject to regulatory rules and sponsor agreement.
How to find an IBD trial
ClinicalTrials.gov, search by condition, location, and recruiting status.
Academic IBD centers and large community practices.
The Crohn’s and Colitis Foundation trial finders and educational resources.
Patient registries and advocacy networks that share opportunities.
Smart questions to ask
What is the purpose of this study, and which phase is it in?
How likely is placebo, and what rescue plans exist?
What visits, tests, and time commitments are required?
How are side effects handled, and who is on call after hours?
What costs are covered, and what happens when the study ends?
FAQs
Are clinical trials only for people who have “tried everything”?
No. Some trials enroll newly diagnosed patients. Others focus on those who did not respond to prior therapies. Phase and design determine who can join.
Will regular care stop during a trial?
No. Trials add scheduled study visits. Usual care continues, coordinated with the study team and the person’s gastroenterologist.
Do participants get to keep the study drug afterward?
Not usually. Continued access may be available in an open‑label extension or through standard prescribing once approved.
Can teens or children join trials?
Yes, when a study is designed for pediatric IBD. Assent from the child and consent from a parent or guardian are required, and safety oversight is similar.