Crohn's disease and ulcerative colitis (Inflammatory Bowel Disease (IBD)), clinical trials provide patients with valuable access to new IBD medications, but not all trials are available to everyone. Learn the important considerations for the timing and types of IBD treatment that you take in order to keep your options for clinical trials open.
We are living in a new era in IBD treatment. Two decades ago, only a handful of Crohn’s and ulcerative colitis (UC) treatments were available, such as steroids and immunosuppressants. Today, multiple new IBD treatments targeting a variety of pathological mechanisms are in development. These emerging treatments target JAK, S1P and IL-23 pathways, among others.
It takes years to bring novel treatments like these from development to market—the only way to get early access to new Crohn’s and UC medications is through a clinical trial.
When to Join a Clinical Trial: Your Window of Opportunity
Especially for IBD patients who often try multiple medications before finding a good fit, it’s important to consider the timing of participating in a clinical trial.
Why is timing important? It may come as a surprise to learn that some clinical trials are limited to participants with a specific medical history. For example, a clinical trial may be recruiting only patients who have previously tried biologic therapy, or only patients who have never taken a biologic.
The key takeaway: if you've failed certain commercial medications, then you may not qualify to participate in certain clinical trials. Keep your options open by researching the available trials any time you are faced with the decision of switching to a new IBD medication. Remember: a trial may be an option now, but whether it remains an option in the future depends on the treatments you choose in the meantime. Clinical therapies all have a window of opportunity for you to try it. If it works, great! You can keep taking it over the long-term (and if not, you can revert to a commercial drug).
Common Questions About Clinical Trials
As you explore your IBD treatment options, you’re likely to hear about clinical trials and the new IBD therapies in the pipeline. However, many patients never take advantage of the early access to new treatments that clinical trials provide out of fear that the clinical trial is unsafe or ineffective. Here are two common questions that surface in the discussion about joining a clinical trial:
Will I feel like a guinea pig in a science experiment?
By the time a drug is in phase 3 trials, there’s already a wealth of data on the drugs’ safety and efficacy. For drugs in phase 2 testing, its safety has already been assessed, with data affirming that the drug has no serious safety contraindications, both for healthy volunteers and for patients with the condition that it is designed to treat.
There’s a common misconception that clinical trials are held in a scientific lab setting. In fact, most phase 2 and 3 trials are undertaken at large health centres, often in the same clinical setting where you’d go to for a GI visit.
What if the medication doesn’t work?
Unfortunately, many IBD patients are accustomed to mediocre treatment results. Current biologic treatments are known to fail a large number of patients (anywhere between 30-50%, depending on the source). With failure rates like these, it’s only natural to be skeptical of IBD treatment results.
At the same time, the high failure rate of current therapies means that there is clearly room for improvement—and this is where new innovations in medicine come in to play. In this sense, joining a clinical trial gives patients another kick at the can, increasing the likelihood of finding a treatment that works as you explore different mechanisms of action, or pathways. There are numerous pathways in the body involved in Crohn's disease and ulcerative colitis—and because doctors can't yet tell which pathway is having the largest impact on your IBD specifically, there will be some trial and error with finding the right medication.
What if I get stuck with the placebo?
In some trials, some participants take the actual drug while others take a placebo. Patients placed on the placebo are usually required to take it for a certain amount of time, after which they can jump onto the drug. Before signing up for any trial, it’s important to ask about your chances of receiving the placebo and the amount of time that must elapse before switching to the study drug.
Don’t Miss Your Window of Opportunity
As you explore your IBD medication options, remember that your eligibility for a clinical trial can be affected by the types of medication you’ve taken prior to the study.
This is important for patients to keep in mind, as taking part in a clinical trial gives you a chance to evaluate a drug that you may not get access to again—or it may be years before you finally see the new treatment commercially available.
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Dr. Remo Panaccione
Remo Panaccione MD, FRCPC in an internationally recognized researcher and expert in IBD diagnosis and treatment. Dr. Panaccione's research is focused on the implementation and performance of clinical trials and on identifying new targets to develop novel IBD treatments. For his significant contributions to the IBD field, Dr. Panaccione was awarded the Finkelstein Award, the highest honor awarded by Crohn’s and Colitis Canada. He is also a dedicated educator, having presented at over 175 lectures across North America in the past 5 years.