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Associate Professor of Medicine
Director, Gastroenterology and Hepatology Fellowship Program
Vice-Chief for Education
Division of Gastroenterology and Hepatology
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
Millie D. Long, MD, MPH, has disclosed that she has received consulting fees from AbbVie, Gilead Sciences, Janssen, Pfizer, Prometheus, Salix, Takeda, Target PharmaSolutions, UCB, and Valeant and funds for research support from Pfizer and Takeda.
For many patients with inflammatory bowel disease (IBD), standard therapies may not be appropriate, or they have not been effective. Some patients would like access to a different type of medication—perhaps an oral agent rather than an injection. Clinical trials provide great opportunities for patients by allowing access to therapies before they are commercially available.
One of the challenges we have faced in IBD clinical trials is that many of our patients have failed so many agents by the time they are enrolled in a trial that we don’t necessarily understand how these drugs work earlier in the course of disease. Recruitment has been difficult and slow, and this has slowed the process of bringing these drugs to market.
There are advantages to discussing opportunities for a clinical trial with a patient, even soon after diagnosis, to help them to understand all their options. In my work as a trialist, I have found that many patients with IBD have never been offered a clinical trial. Having these conversations earlier in the course of their disease can be helpful, not only for the patient to have other treatment options, but also for the IBD community.
Barriers to Enrolling in Trials
A common barrier for patient enrollment in clinical trials is geography. If patients must travel a significant distance to participate, that can discourage them from enrolling. It is helpful for patients and community practitioners to know that many trials provide support, including hotel accommodations and travel reimbursements, that can help overcome this barrier.
Another barrier is missed work. Participating in a clinical trial can involve frequent appointments with rigorous assessments, and patients need appropriate reimbursement for that. Newer trials have modified procedures to provide that reimbursement.
Moreover, patients want the support of their primary gastrointestinal (GI) provider before enrolling in a clinical trial. As a patient’s primary GI provider, it is helpful to express that you feel comfortable with the trial and reassure the patient that he or she will receive appropriate and safe care. It is also helpful to know and communicate that the patient will always return to the referring provider at the conclusion of the trial, ideally once his or her disease has improved.
Many patients are hesitant to participate in a clinical trial out of fear of flaring if the investigational drug is ineffective or if they receive placebo. Likewise, fear of unanticipated adverse events is common. One way to help patients feel more comfortable with these issues is to have a conversation about how the clinical trial process works.
Prior to consent in a clinical trial, the investigator will discuss the therapy in detail with the patient. Moreover, there is a rigorous safety process in clinical trials; patients are monitored extensively. As a trialist, I advise patients about the independent data and safety monitoring board and explain that, overall, the trial is designed for safety and the patient comes first. If ever patients are not doing well, we pull them out of the trial. Patients may also take comfort in learning that many trials offer an open‑label extension, such that participants who were initially randomized to the placebo group will have guaranteed access to switch to the active agent.
IBD Partners is an online cohort that has been operating since 2011, in which we collect longitudinal data on patient‑reported outcomes to help us understand how IBD drugs work in the real world. Individual patients can self‑enroll at www.ibdpartners.org; more than 15,000 patients have joined.
Using the IBD Partners cohort, we were able to ask whether patients had participated in a clinical trial, allowing us to characterize patients who do and do not participate. Of interest, we found those who participated were more likely to be seen at an academic institution. Among those who had not participated in a trial, many had active symptoms and inflammation. We saw other large gaps in the characteristics of participants vs nonparticipants. Older individuals were less likely to participate, as were patients who were earlier in their disease course. This kind of data can help us design studies that include all patients who could potentially enhance enrollment.
Outreach efforts from the Crohn’s and Colitis Foundation have also been helpful to promote recruitment. Its “Clinical Trials Community” offers patients a resource to find clinical trials near them that they might be eligible for or interested in as well as education about what a trial is. There are now clinical trial ambassadors, or patients who have participated in clinical trials, who can share their experience. All of this is important and might lead patients to ask their primary care providers about options for a clinical trial.
Advancing the Field
Improving awareness of and enrollment in clinical trials will help to move the field forward as we move from placebo‑controlled trials to comparative effectiveness trials. These head-to-head comparisons of IBD therapies will depend on recruiting patients who are earlier in their disease course. I encourage practitioners to have conversations about IBD clinical trials earlier and to be aware of the clinical trial options in your community.
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