IBD is an umbrella term for two diseases — ulcerative colitis (UC) and Crohn’s disease (CD). These are chronic inflammatory diseases of the digestive tract. Crohn’s disease can affect the entire digestive tract, whereas UC specifically refers to inflammation of the large intestine (colon). Despite this difference, the two diseases share symptoms — which may include abdominal pain, persistent diarrhea, and bloody stool.
Not only do both Crohn’s disease and ulcerative colitis have a tremendous negative impact on patients’ lives, they also increase healthcare costs. A 2019 study found that patients with IBD incur direct annual healthcare costs of $22,987 on average, while non-IBD patients incur $6,956. That is a 230% difference in annual cost!
To date, there is no known cure for IBD — despite the impact these diseases have on patients and our economy.
There are, however, medical and surgical treatment options. Medical treatments include aminosalicylates, corticosteroids, immunomodulators, antibiotics, and biologic therapies. These treatment options aren’t perfect though — according to The Mayo Clinic, “more than one-third of patients with IBD fail induction therapy and up to 60 percent of primary responders lose response over time.” Basically, for the majority of sufferers, current treatment options tend to either not work at all, or cease working over time.
Researchers and pharmaceutical companies are actively developing new and improved therapeutic options for patients. Unfortunately, commercializing new IBD drugs is a costly and time-consuming endeavor.
This challenge is amplified by intense competition for trial-eligible patients. A 2019 study found that 47 companies are actively conducting trials for 70 investigational or approved drugs.
That's a good number of companies and a great number of new drugs. But, it is estimated that over 48,000 patients will be needed to fully enroll all of these trials.
To make matters worse — IBD drug trials are notoriously bad at enrolling patients. The average trial site in an ulcerative colitis study enrolls only 0.13 patients per month, while the average site in a Crohn’s disease study enrolls only 0.10 patients per month.
As I hope we’ve made clear with the above primer, IBD is debilitating for those that suffer from it, and the treatment options available are both failure prone as well as incredibly taxing on our economy. And, although drug manufacturers are focused on solving the efficacy problem through developing new drugs, there are still unanswered questions and problems to solve when it comes to how we get these drugs to patients, quickly.
This is the first in a series of blog posts that will examine what’s wrong with IBD trials. We’ll examine the problems from three key perspectives — the patients, the healthcare providers, and the pharmaceutical companies. Then we’ll look at how various technological advances could help improve the current state of affairs. Our hope is that this information will help others understand what causes inflammatory bowel disease trials to take such a long time so that we can collectively solve these problems and help get new treatments to patients faster.
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