Inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis, cause chronic inflammation in and damage to the gastrointestinal (GI) tract in 1.6 million Americans yearly. The gastrointestinal (GI) tract plays a crucial role in processing food, extracting essential nutrients, and expelling waste. Inflammation disrupts the normal functioning of these GI organs, resulting in symptoms like enduring diarrhea, abdominal discomfort, rectal bleeding, weight loss, and fatigue.
These symptoms wreak havoc on sufferers, harming their ability to enjoy a healthy life. While some treatments have been developed to aid with these ailments, IBD isn’t going away anytime soon – in fact, the number of patients with IBD has been increasing worldwide. Although existing medications perform relatively well, treatment failure and severe side effects have been observed in some patients – driving the search for alternative, effective drugs.
However, recruitment remains a prominent pain point for IBD drug trials. Without substantial recruitment numbers, drug manufacturers have little hope of achieving FDA approval of necessary medication for IBD sufferers. To put the problem in context, enrollment rates are between 0.08-0.12 patients per year per site due to difficult enrollment criteria1,2. This is far too low, leading to a delay in the approval process for life-changing medication.
So what makes it so tough to acquire the right candidates? On the patient side, participating in a clinical trial requires sacrifice.
Eligibility requirements are strict for IBD clinical trial enrollment. For example, candidates must have moderate to severe IBD in flare. Women of childbearing age must be on multiple birth control medications. In addition, there are age, vaccine, surgery, medication, and other disease requirements that must be met.
Predictably, many patients decline to participate because it requires additional colonoscopies, which are unpleasant to prep for. If a patient is found to be completely eligible, and are enrolled in the clinical trial, they may still be randomized into the control arm, meaning that they will receive the placebo instead of the trial drug, leaving them right where they started.
This is where Manisha Cole comes in.
Before joining the Virgo team, Cole served as clinical research staff at Boston Medical Center in the Department of Pathology. As a Senior Life Sciences Associate at Virgo, her main duty is to utilize procedural video footage to increase the patient pool for clinical trials. Possessing a deep understanding of the research side of medication approval, Cole is the ideal person to manage Virgo’s new patient recruitment tools.
As a testament to her work, her research was accepted as a poster presentation at the annual ACG conference. According to Cole, “There’s just so many minute criteria that patients must adhere to in order to be accepted for trials. On the researcher’s side, it’s not much more straightforward either. That’s because clinical researchers are extremely overworked and underpaid. Researchers are also often in charge of sifting through thousands of patients at any given time, trying to recruit for multiple trials or studies at once.”
So where does Virgo come in?
Cole recently detailed how she utilizes Virgo’s AutoIBD for patient organization. (AutoIBD is a machine learning algorithm that sorts through patients’ standard of care endoscopy videos and flags any that may be likely to meet the trial endoscopy requirement.) Rather than manually sorting through hundreds of patients, Cole can help trial sites pull specific candidates with a flare, drastically cutting their search time—and of course, funneling more candidates into potential trials.
As Cole explains, “Now that I can offer more patients who are likely to meet eligibility criteria, we can present higher-quality referrals.” It is important to note that when it comes to trial participants, quality beats quantity. Using Virgo, researchers can screen more patients using a list of criteria that can define if a candidate is likely eligible.
“Clinical research staff also like using Virgo. It’s a great system that saves a lot of time,” Cole adds. Part of the reason why is its ease of use. Virgo’s user interface is much more visually-based and user-friendly than tools of the past. Also, with Virgo, assessments can be automated, with data being pulled directly from the system into CSVs, a huge improvement to tedious Excel spreadsheets for data management.
Another benefit Cole highlights is the speed and breadth at which Virgo integrates into hospital systems. Typically when Virgo is installed in a hospital, it’s then installed across the whole system. For example, in an academic hospital setting, when Virgo is installed on the main campus, it’s also installed in that system’s outpatient centers and community hospitals.
Not only is Virgo helping to get more quality candidates in trials, but it’s improving candidate diversity. “After all, drug outcomes can vary wildly based on age, gender, ethnicity, socioeconomic conditions, etc. To have the most effective medication, you must ensure its effects on a diverse patient population is known.” says Cole.
There is still a long road to go when it comes to IBD clinical trial recruitment, but Virgo is confident it can increase overall enrollment rates and diversity in clinical trials via its patient recruitment system that can scan a far wider breadth of potential candidates than ever before. Even better, the implementation of tech for capturing and sharing procedures has resulted in the identification and engagement of a larger number of patients by study coordinators, including those who might have been missed otherwise. And with machine learning capabilities improving every day, Virgo’s AI recruitment tools will only increase.
“Successfully recruiting diverse and quality candidates will lead to shorter trials moving forward, which means faster approval and rollout for life-changing medication—all wonderful positives,” says Cole. For now, unknowns swirl around IBD, but experts like Cole continue to shed light on these ailments thanks to Virgo’s innovative solutions. If you’re interested in learning more about patient recruitment in IBD clinical trials, come say hi to Manisha and check out her poster at ACG in Vancouver, poster #P0680.
- Mathieu Uzzan and others, Declining Enrolment and Other Challenges in IBD Clinical Trials: Causes and Potential Solutions, Journal of Crohn’s and Colitis, Volume 17, Issue 7, July 2023, Pages 1066–1078,
- Rubin DT, Peyrin-Biroulet L, Reinisch W, Tole S, Sullivan L, Park KT, Regueiro M. Inflammatory Bowel Disease Patients’ Perspectives of Clinical Trials: A Global Quantitative and Qualitative Analysis. Crohns Colitis 360. 2021 Dec 9;3(4):otab079. doi: 10.1093/crocol/otab079. PMID: 36777264; PMCID: PMC9802428.