The key to finding new treatments for IBD: clinical trials
Published: May 20, 2021
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:
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:
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:
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:
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:
Rebecca Kaplan is the Associate Director, Marketing & Communications for the Crohn's & Colitis Foundation and the caregiver of a Crohn's disease patient.