7 Myths About Ulcerative Colitis Clinical Trials That Keep People From Exploring Them

Clinical trials are research studies that test whether new treatments are safe and work. They rely on volunteers to take part. Clinical trials are critical because they’re the only way researchers know if treatments are effective and meet safety standards. By taking part, you could help improve the health of others who would eventually use the treatment. There are different types of clinical trials, but a common one is a treatment trial, which tests new or existing drugs, devices, and other treatments.

Fact: Many people think clinical trials are only for those with serious health problems who’ve run out of treatment options, but these trials can help people at different stages of a condition, including ulcerative colitis (UC). Some clinical trials test new treatments or ways to help you avoid disease. Others focus on improving current treatments. Some trials aim to cut down on unnecessary treatments by shortening them or replacing older therapies that may cause long-term side effects or other symptoms.

Fact: You’ll most likely get a new treatment or the current standard of care, not a placebo alone. A placebo (“sugar pill”) is a treatment with no effect. Many times, clinical trials are “blind,” which means you and your doctor won’t know which treatment you’re getting. Researchers randomly assign you to one of two groups: the intervention group, which gets the new treatment being tested, or the control group, which gets standard treatment along with a placebo.

Fact: Most clinical trials, including for UC, need more people. More than 70% of clinical trials are delayed by at least a month because not enough people enroll. This slows drug approval and means fewer treatments are available. But although researchers are looking for more people to take part in clinical trials, you’ll still have to meet certain guidelines. These include things like age and health status. These guidelines are designed to protect you and help researchers fully understand the effects of a treatment.

Fact: There’s always some risk with medical treatment, whether it’s a new therapy or one that people have used for a long time. Still, researchers thoroughly study treatments in a lab setting before the FDA allows testing in humans. Every trial follows strict rules to make sure people stay safe. Researchers and doctors also follow patients throughout the trial to check for issues related to treatment. If you have any serious negative effects during a trial, the researchers will stop it.

Fact: Private or federal funding usually covers the costs of conducting clinical trials. Your health insurance also often covers some costs of routine care during the trial, such as lab tests, doctor visits, imaging scans, and approved treatments. The trial sponsor will pay for the rest. Talk to your doctor or the clinical research team about any extra costs before you start treatment. Many hospitals also have financial counselors you can contact to discuss insurance or billing questions.

Fact: You’re allowed to leave a clinical trial at any time, for any reason. In keeping with federal rules, researchers must let you know that you can withdraw from an ongoing study and the impact of your decision. It’s best to let the research team know you’re dropping out — you can give them a reason, but it’s not required. If you leave a trial, you’ll likely need to attend a final visit and any follow-up visits to check for side effects.

Fact: Beyond drug trials, there are other kinds that you can take part in as someone living with UC:

• Prevention trials test new ways to stop UC from starting or coming back
• Diagnostic trials test new methods to diagnose UC
• Screening trials try to find better ways to spot UC
• Genetic trials test ways to predict who might get UC
• Quality of life trials study new ways to make life better for people with UC

Here are some things to think about before signing up for a clinical trial:

Understand the pros and cons. Weigh benefits such as access to new treatments against risks such as side effects, extra procedures, or time commitments.

Understand the informed consent process. This means a clear explanation of the study’s purpose, what participation involves, alternatives, and your rights. 

Learn more about available clinical trials for UC from your doctor or groups like the Crohn’s & Colitis Foundation.