Answered! Top Questions About UC Clinical Trials
Clinical trials can determine the most effective and safest treatments for a wide range of diseases, and sometimes help launch exciting new therapies. If you’ve ever wondered about what it would be like to join a clinical trial for ulcerative colitis (UC), we’ve got the answer! We asked two physicians who’ve led teams of researchers, plus an actual trial participant, to give us the inside scoop on what it’s really like advancing the science around UC.
How Hard Is It to Join a UC Trial?
There are currently about 400 clinical trials in the U.S. that focus on UC. “The ease of joining a trial depends on the indication, your geographic region, and access to a recruitment site,” says Ashwin Ananthakrishnan, M.D., an associate professor of medicine at Massachusetts General Hospital and Harvard Medical School in Boston. Since each trial has a strict set of guidelines, not every study is open to everyone who wants to join it, notes Seymour Katz, M.D., clinical professor and director of the Inflammatory Bowel Diseases Outreach Programs at NYU Langone in New York City.
How Can I Find a Trial Near Me?
The first step? Talk to your doctor. Thomas, who prefers to share his first name only, lives in Northern Kentucky and has been a UC trial participant since 2019. “Finding a UC trial to participate in was easy for me because my doctor was at the University of Cincinnati, where they do a great deal of clinical studies,” he explains. “Most teaching medical centers offer different clinical trials, or at least will be able to point you in the right direction.” For info on ones near you, go to clinicaltrials.gov—they list all active trials, Dr. Ananthakrishnan says.
Are Placebos Ever Used?
Some UC trial participants are given the medication being researched, while others may be given a pill that does not contain any active ingredients at all—a powerless intervention called a placebo. According to Dr. Katz, placebos are indistinguishable from the actual drug under review and “are almost always used in clinical trials because they help sort out how much the experimental treatment is working, versus how much a person is just getting better by being in the trial.” Participants can opt out from placebo if they choose.
What Happens If I’m Given a Placebo?
Oftentimes, clinical trial participants who find themselves in the placebo group—a.k.a., the “control group”—are given the option to take the drug being tested, usually after about 8 to 12 weeks, when enough information has been collected. Most phase 3 trials are designed so that all participants get access to the study drug before the trial ends, according to research. Usually, those in the control group are not required to discontinue their current medication (so you won’t be going without any therapy at all).
What if My UC Symptoms Increase During a Trial?
Both Drs. Ananthakrishnan and Katz maintain that patient safety comes first in any clinical trial—and UC trials are no different. “From the beginning to the end, participation in a trial is entirely optional,” Dr. Ananthakrishnan further clarifies. “If your condition worsens, your doctor will be allowed to make changes to your treatment regimen. While these changes may result in your withdrawal from the trial, there will never be a circumstance where an intervention required for your health will be withheld because you are in a trial.”
Can I Take a New Drug After a Trial Ends?
It’s possible. Whether or not you can stay on the treatment after the trial ends will depend on the trial itself, says Dr. Ananthakrishnan. “Many trials offer what’s called open-label continuation, or open-label extension of the treatment, for a few years after the trial ends,” he explains. That means participants are invited to enroll in a subsequent study that is usually longer than the initial trial. All participants in the new extension study are given the study drug, and both the participants and investigators know this.
Will I Have a Support System?
“In a trial, you usually have continuous and comprehensive care that includes nutritionists and specialized nurses,” Dr. Ananthakrishnan explains. Thomas says he was pleasantly surprised by his experience. “Once I entered the study, I was amazed at the amount of attention I received from my study nurses. They were there 24/7 with any need, concern, or worry I had,” he reports. “They’ve been angels through all of this.”
Will I Be Paid?
According to Dr. Katz, “Participants do not usually get paid to participate in a clinical trial, but sometimes travel or food stipends are available.” For example, some clinical trial sites will help arrange transportation and hotel accommodations if you are traveling a distance in order to participate. And, according to the Crohn’s and Colitis Foundation, depending on your eligibility, and whether or not your physician and the study team consider you a good candidate, you may receive the study drug during the trial at no cost as a participant.
How Long of a Commitment Is It?
Clinical trials are conducted in a series of steps, called phases. Each phase is designed to answer a separate research question. According to Thomas, how long the clinical trial lasts depends on various factors, such as “what phase the trial is in and whether or not I respond to it. I’ve been in this study for over two years and have never been given an end date,” he says. Some trials can be 4 to 12 weeks in length, while others can last for a number of years. “It’s a rewarding feeling to help advance UC research,” Thomas adds.
What It’s Like Participating in UC Research?
“People view clinical trials as experiments, and often don’t want to be treated as ‘lab rats,’” says Dr. Ananthakrishnan. But he insists “that’s not the right perception. Clinical trials offer you the opportunity to try new medications—usually with different mechanisms—and [they are] often safer than existing medications, years before they’re available on the market.” Dr. Katz emphasizes the importance of participation. “Clinical trials are some of the only ways we get somewhere [in the fight against a disease], and these trials are critical for therapy and drug development.”
About UC Clinical Trials: Crohn’s & Colitis Foundation. (2021.) “Clinical trials.” https://trials.crohnscolitisfoundation.org/
Finding a Clinical Trial: U.S. National Library of Medicine. (2021.) “ClinicalTrials.gov.” https://clinicaltrials.gov/
On Placebos: National Cancer Institute. (2021.) “NCI Dictionaries.” https://www.cancer.gov/publications/dictionaries/cancer-terms/def/placebo
Continuing Treatment: The British Medical Association. (2005.) “Open label extension studies: research or marketing?” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1200598
Length of Treatment: Crohn’s and Colitis Foundation. (2017.) “Clinical trials frequently asked questions.” https://www.crohnscolitisfoundation.org/sites/default/files/2020-04/05-17-448-CC-FAQ-Infograph-PRINT.pdf