We’re back with the second part of our series on the challenges associated with inflammatory bowel disease (IBD) clinical trials. For this post, we’ll be exploring these challenges from the most important perspective — that of the patient.

Without patients, the IBD trials required to get new drug approval simply cannot happen. And — as mentioned in part one of this blog series — researchers estimate that nearly 50,000 patients are needed to fully enroll just the currently active IBD trials.

And what makes it so difficult for patients to enroll in trials?

First of all, research participation by a patient is completely voluntary and requires patient consent. Patients should work closely with their medical care providers to determine if participation in specific trials is safe and recommended. An investigational therapy simply may not fall within a patient's care plan, which immediately reduces the population eligible for a trial significantly.

There are potential benefits to participating in IBD trials, which include:

  • Early access to new therapy options
  • Free access to the treatment for the trial
  • Reimbursement of travel expenses
  • Contribution to scientific advancement

However, IBD trials do have some potential downsides, namely:

  • Participation may require significant travel commitments and multiple visits
  • Some trials are longer in duration than others
  • Most trials contain a placebo arm, meaning an individual patient may not end up receiving the investigational therapy
  • Participation often includes multiple endoscopies

Although there are clearly many potential benefits to participation, the potential downsides mentioned often outweigh the benefits from a patient’s perspective, further reducing the enrollable population.

The Crohn’s & Colitis Foundation conducted a series of very informative patient focus groups to better understand how patients think and feel about participating in IBD clinical trials. Of the 34 patients in the focus groups, 9 had previously participated in clinical research.

Patients in the focus group stated that the potential to help others and also possibly themselves was a major attractive factor for participating in trials. However, common concerns included unknowns about possibly being placed in a placebo group, unforeseen side effects, and other impact to their daily lives (impact on child bearing, need to get multiple endoscopies, etc.).

Many patients also reported that engagement with their primary care physician (PCP) and primary gastroenterologist (GI) is a major deciding factor in trial participation. Unfortunately, one study found that only 23% of patients receive information about trials from their PCP.

This echoes the experience of one patient we spoke with. About a year ago, the patient first saw a private practice gastroenterologist when he started feeling off with persistent GI symptoms. However, that doctor was doing as the patient puts it, “churn and burn colonoscopy” without giving particularly deep thought to his care. Eventually, he was diagnosed with moderate to severe ulcerative colitis and prescribed mesalamine followed by prednisone.

When his symptoms persisted, the patient sought out a second and eventually a third opinion from IBD experts at two academic medical centers with world-renowned IBD programs. In doing so, he saw firsthand the communicative limitations between various healthcare providers. Even within an individual system, it was difficult for his gastroenterologist and endocrinologist to exchange information.

This patient told us that some of the best advice he received was to “learn to become a professional patient”.

Because his doctors at various institutions couldn’t easily share records, he became his own centralized records management system. Unfortunately, the records he obtained included either low-quality imagery, or no imaging whatsoever. This is very important, as visually examining the disease state of the bowel is critical to triaging the effectiveness of any one treatment over another.

This patient's experience as an IBD patient isn’t uncommon, and the lack of transferable records often leads to additional colonoscopies for patients. Furthermore, patients seen in the community setting or in private GI practices often aren’t exposed to the same opportunities to participate in clinical research as patients who go to academic medical centers.

Moreover, by the time many IBD patients eventually do make their way to academic centers, their eligibility for various trials may have passed or they might require repetitive colonoscopies in order to enroll.

As you can see, the current state of inadequate procedural documentation and transferability not only places undue burden on patients, it also unnecessarily restricts the population available to participate in research studies.

The IBD patient journey is always top of mind for us at Virgo, and in the final blog post of this series, we’ll cover how we think Virgo can make the situation better for patients. In the meantime, if you’re a patient with IBD who is interested in learning more or sharing your story, we would love to hear from you!

Stay tuned for the next post in this series, which will cover the challenges associated with IBD clinical trials from the healthcare provider’s perspective.