The key to finding new treatments for IBD: clinical trials

Published: May 20, 2021

By: Rebecca Kaplan

Finding a treatment that works to treat IBD patients’ symptoms and help induce remission is important. But these treatments wouldn’t be available without clinical trials. In fact, every single IBD medicine currently available on the market is primarily there because of clinical trials and the patients who participated them.

Despite the critical importance of clinical trials, there are many myths that surround them and deter people from enrolling. In fact, more than 70% of clinical trials are delayed at least one month due to unfulfilled enrollment. This creates significant barriers to the drug approval process and results in fewer available treatments for Crohn’s disease and ulcerative colitis.

We shouldn’t fear clinical trials – in fact, they play a critical role in IBD research and have a hand in improving not only your own health but also the health of millions of others in the future. As Melissa, a former clinical trial participant, said:

“While the prospect of being in a trial can be scary, without trials there would be no medication approved for IBD. If my participation in a trial can help not only me, but other IBD patients I will always be willing to participate.

Here are a few of the common myths we hear about clinical trials and the truth behind them:

MYTH: Clinical trials aren’t safe

FACT: Investigational treatments or other protocols must be studied extensively in the lab before the U.S. Food & Drug Administration will approve it to be tested in humans. Each trial has extensive protocols it follows, all to ensure the health and safety of its participants. Additionally, patients are followed continuously throughout a trial to monitor for any study treatment-related issues.

Despite having initial concerns about safety, Mary enrolled in a trial that her doctor recommended. The trial ended up significantly improving her quality of life:

“I developed anemia due to my Crohn’s, and my gastroenterologist suggested I try a clinical trial involving iron infusions that he would be running with the gastroenterology department. My doctor explained how this trial could be beneficial to me, and that it would be helpful for research as well. I was worried that I would have an adverse reaction to the infusion and that I wouldn’t be able to know anything about what I was taking. Both proved to be false. The trial ended up being great for me and my anemia improved significantly, something my doctor and I were thrilled about.”

MYTH: Clinical trials are expensive

FACT: Most clinical trials are federally or privately funded, so there is typically no cost to participate. Federal law requires that most health insurance plans cover most of routine patient care costs associated with clinical trials. However, it’s important to know that health plans are not required to cover all research costs, such as extra blood tests or scans that are done for research purposes. Oftentimes, the trial sponsor will cover those costs.

MYTH: Once I join a clinical trial, I can’t change my mind

FACT: You can drop out of a clinical trial at any time! Research coordinators will discuss this at length with you during the consent process to enroll in a trial. Michelle was enrolled in a clinical trial and her symptoms began to improve. However, during the second randomization (the process in which people are selected by chance to receive the study drug or placebo), she began to get sicker:

“It was time for the second randomization during the trial, and this time I had a 50% chance of receiving the study drug. Unfortunately, within two weeks after that midway point, I was back to being very ill, concluding that I had gotten the placebo. As there was no open label (when you know what study drug you are taking) for this trial, we decided it only made sense for me to pull out. Even though it was devastating to go through that, I would do it all again. Not only were those two months the best for me, but knowing that I was a part of something that could help people in the future and not have them suffer is something that I will always be proud of taking part in.”

If you decide to drop out of a trial, you will likely be asked to complete a termination visit and any safety follow-up visits to ensure you do not experience any side effects.

MYTH: There are no types of trials aside from medication ones

FACT: Although many clinical trials involve an investigational treatment or drug, there are five other types of trials that patients can participate in:

Prevention trials look for better ways to prevent or lower the risk of getting IBD or having it return
Diagnostic trials look for better ways to diagnose IBD
Screening trials seek to find better ways to detect IBD or IBD-related complications earlier in people who are at high-risk
Genetic trials look for methods to predict if a person will get IBD by identifying and learning how genes are related to IBD
Quality of life trials research new ways to improve the comfort and quality of life for people with IBD

Emilia, a pediatric Crohn’s patient, has participated in three trials, none of which involved a medication. According to her mom:

“She wanted to participate because she knows it could help another child. The first one was a yoga and IBD trial where she participated in children’s yoga classes and completed questionnaires to record her IBD symptoms. Another was a microbiome study where she completed food logs and symptom diaries. The third was a study which utilized interviews with the patients only. She has enjoyed participating in these studies.”

MYTH: If there is a clinical trial that might help me, my doctor will tell me about it

FACT: We hope that this is true, but in many cases, doctors may not be aware of clinical trials In fact, research shows that 69% of IBD patients have not been invited to participate in a clinical trial.

If you are interested in participating in a clinical trial, we encourage you to do some research yourself! The Foundation’s website has a Clinical Trials Finder where you can search for trials that you may qualify for. We also feature specific trials, like this one, and other educational resources on our Clinical Trials Community. If you find something near you that is of interest, share information with your doctor and ask them if they think it would be a good option for you.

Here’s some final advice from Nick, an IBD patient and past clinical trial participant:

“Never be afraid to ask questions and do your research. The trial ended up changing my life to the point of never wanting it to end! We all know what it’s like to feel the frustration and helplessness that can come with IBD…I have been in remission for well over a year, and my quality of life has never been better.”

Rebecca Kaplan is the Associate Director, Marketing & Communications for the Crohn's & Colitis Foundation and the caregiver of a Crohn's disease patient.

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