Living with inflammatory bowel disease (IBD) can cast a shadow on the future of a person’s life, but there is a light often overlooked when considering care options: clinical trials. They represent the future of IBD management, given the focus and investment on finding new therapies and treatments.
Given my personal experience with clinical trials, as well as added knowledge from the American Gastroenterological Association (AGA) IBD Patient Influencer education program, I am confident that clinical trials can play a critical role in IBD care. I want fellow patients to understand how clinical trials can help them better manage their IBD, whether as an entry point into therapeutics or after exhausting several treatment options.
Overview of Clinical Trials: Beyond the Lab Coats
For new a IBD medication to become available in clinical practice, it goes through a rigorous research process before reaching the patient population. The phases are:
- Discovery and Preclinical This is the initial phase in which multiple drugs are studied in preclinical IBD models (such as animals) to determine targets.
- Phase I This is conducted in a small number of healthy volunteers or patients who have not responded to currently approved treatments, with a goal to determine impact of low and varying doses of the medication in human beings. This phase helps determine how the medication is metabolized by the human body, as well as how quickly the body clears the medication.
- Phase 2 Various doses of the medication are tested in IBD patients to determine the impact on disease outcome and safety. The primary purpose of this phase is a proof of concept, or a validation of feasibility, to assess if the drug is having a positive impact on specific IBD pathways — the biological processes that lead to inflammation of the intestinal barrier.
- Phase 3 In phase 3, the trial is conducted in a much larger population with a greater number of IBD patients. Most clinical trials are done in people with moderate to severe disease. This phase requires two trials of induction therapy. The doses tested in phase 3 are those determined to have been the most effective in phase 2. The primary purpose of this phase is to determine if the drug is effective in improving disease outcomes.
- FDA Approvals The final step in drug development is submission of clinical trial data to the FDA, which interprets and reviews available data from all trial phases. Typically, only 10 percent of compounds that enter phase 1 advance to an FDA approval, according to research.
The Clinical Trial Process: Navigating the Unknown as an IBD Patient
We can choose to play an active role if we participate in clinical trials. For IBD patients to enroll in clinical trials, there are important inclusion criteria to consider, typically including: level of disease activity, severity of symptoms, and endoscopic activity, along with exposure to other IBD medication. Exclusion criteria can include a high disease burden but low endoscopic activity, or with altered anatomy, such as with ostomies, J-pouches, or fistulae.
Interestingly, only about one-third of IBD patients seen in the clinic are eligible for clinical trials. Of the eligible patients, those with similar disease activity will be selected based on inclusion/exclusion criteria. Patients are randomized to the study, meaning the dose of the drug they are given (or if they are in the control group) is determined randomly by a computer-generated program, versus being determined by the researcher, eliminating any possible bias by the research team. This can mean patients are receiving different drug levels or sometimes even receiving a placebo. Studies are “double blind” because neither the researcher nor the patient knows whether they are receiving a drug or the control.
In most studies, researchers follow up with patients every 1 to 2 weeks for the first 8 to 12 weeks, with continued follow-up every 8 to 12 weeks thereafter. This helps determine which arms of the trial are successful, as well as confirming compliance along the way. At the end of the trial, the patient’s outcome is determined based on measurable objectives such as clinical disease activity, biomarkers, imaging, and endoscopic status.
Bridging Cultural Barriers in Clinical Trials
Diversity in IBD clinical trials is crucial given the current racial makeup of clinical trials, which are primarily conducted in the Caucasian population. Research shows Hispanic/Latino and Black/African Americans are very underrepresented in IBD clinical trials, even though the disease has evolved significantly in all demographics.
Fortunately, there are more priorities to diversify IBD clinical trials, including grassroot recruitment efforts, trial design improvement, and standardized reporting to improve race and ethnicity data.
In this mock telemedicine consult video, I was the IBD patient inquiring about clinical trials with a healthcare provider, all in Spanish. Utilizing educational content videos can help reassure Hispanic/Latino patients about clinical trials. As a Latina Crohn’s disease patient advocate, I feel it is important for me to utilize my voice to break down any language barriers that may exist.
Finally, the Crohn’s & Colitis Foundation is developing clinical trial workgroups to increase clinical trial engagement and promote clinical trial resources among diverse communities. I was recently selected to join this workgroup to provide my voice, experiences, and feedback. I’m eager to contribute my perspective as a Latina IBD patient and to explore barriers to participation, build consensus on which patients should be referred to trials, aid in designing trials that reflect patients’ needs and education, and expand outreach about clinical trials. For more information, check out the Clinical Trials Community.
Clinical trials can play a transformative role in our IBD journeys. I encourage patients to be open to considering clinical trials through shared decision-making with their healthcare provider. Clinical trials are not just medical endeavors but also the hope for the future of IBD. Each step we take as patients in the name of research is a step forward. By choosing to participate, we contribute to the advancement of medical knowledge, but more importantly we empower ourselves to be champions of our own health.
To learn more about clinical trials or to join one, you can visit ClinicalTrials.gov.
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