Summary
Virgo’s innovations in the field of IBD clinical trials add value for patients by reducing unnecessary screenings, payments, and extraneous suffering, while increasing patient exposure and enrollment opportunities for those trying to receive novel therapies.
Refractory Inflammatory Bowel Disease (IBD) patients face many challenging decisions in managing their condition. Unfortunately, effective medical management may often feel out of reach with limited biologic drug options and remarkably high drug costs. Per the Crohn’s and Colitis Foundation, around a third of Ulcerative Colitis patients and 75% of Crohn’s patients will eventually require surgery. However, when patients look beyond surgery for novel medical therapies, they often encounter many barriers to clinical trials.
Due to limited clinical trial site availability and burdensome protocols, eligible patients often miss out on or decline the opportunity to participate in IBD clinical trials. Almost all IBD clinical trials require a baseline/screening endoscopy to determine eligibility at a trial site. As a result, patients must often return to the clinic for a repeat endoscopy.
The preparation and two-day disruption that accompanies most endoscopies are onerous for patients. Requiring patients to return for an additional follow-on endoscopy during a flare is an unnecessary standard that disrupts the patient’s daily life. Most commonly, the purpose of the second screening is to capture high-quality disease video data since taking still photographs remains the current standard of care in endoscopy. Rarely is there a significant change in endoscopic findings for stable, refractory IBD patients between the first and repeat endoscopy, especially if there is no change in their treatment plan.
Unless this endoscopy is emergent, this repeated test is wasteful and discouraging – perhaps preventing a patient from pursuing a clinical trial. A patient who chooses to participate in a clinical trial will likely undergo an array of physical testing as well; removing the need for an extraneous endoscopy reduces the barrier to entry and improves the experience for patients.
Virgo’s always-on video recording platform offers a solution for this limitation.
Pharmaceutical sponsors may use Virgo’s video capture device to record scheduled diagnostic or surveillance endoscopies per a patient’s standard-of-care protocols – these recordings may then be used as referrals and as baseline endoscopies for data in their clinical trials. In this scenario, a payer may save up to $4,000 per patient using Virgo’s video capture platform while accessing a higher-quality, more robust dataset.
Furthermore, clinical trial sites are often a single flagship location within an extensive hospital network. Virgo’s platform enables video recordings from affiliate sites to be shared with the primary investigator/clinical research coordinator at the flagship trial site so that patients who otherwise wouldn’t have access to these trials can be referred and enrolled in a decentralized model.
In summary, Virgo’s innovations in the field of IBD clinical trials add value for patients by reducing unnecessary screenings, payments, and extraneous suffering, while increasing patient exposure and enrollment opportunities for those trying to receive novel therapies.
Written By: Nino Barbati
Nino is a Life Sciences Associate Intern at Virgo and a current student at Georgetown University studying economics and public health. As an Ulcerative Colitis patient who has personally experienced the shortcomings of IBD care, Nino is excited to join Virgo’s mission to improve patient outcomes and clinical workflows specific to patients with GI-related conditions.