P0680 - Endoscopy Recording in Inflammatory Bowel Disease Clinical Trial Recruitment

Manisha Cole, , Safia Speer, , Brandon Davis, , Ian C. Strug, , Matt Schwartz,
Virgo, Carlsbad, CA

Introduction: Recruitment for irritable bowel disease (IBD) clinical trials requires significant time and finances, as only 3-4% of patients eligible for a trial participate. Current limitations cost IBD patients access to life changing medication, and pharmaceutical companies significant loss of revenue. For each phase of a clinical trial, pharmaceutical companies may recruit patients from a few to 200 facilities, ranging from small private practice endoscopy centers to large, world renowned academic medical centers. Sites recruit an average of 1 patient per year per trial. Introducing automated endoscopy recording to recruitment facilities, recruitment effort extends to community sites, as all doctors from the medical center can readily recruit for each ongoing trial.

Virgo is an automated video capture system that, while recording video, streams to a HIPAA compliant cloud, where site staff can access chronologically indexed recordings.

Methods: Virgo was installed for standard of care and clinical trial recruitment use at two recruitment facilities, sites A and B. Site A was a large, multi-endoscopy center, private practice with 12 endoscope processors at 4 sites in May, 2021. Site B was an academic medical center where Virgo was installed on 5 endoscope processors in August, 2021.

Physicians at both sites began using Virgo in an automated fashion immediately after installation, recording every case performed. This continued from site installation to February, 2023 for site A and July, 2022 for site B.

Three clinical trials were completed during this time, trials 1, 2, and 3. Trial 1 and 2 were both conducted at site A, while Trial 3 was conducted at site 2. Trial 1 was a phase 2 Ulcerative colitis (UC) trial, aiming to enroll 120 patients. Trial 2 was a phase 3b Crohn’s disease (CD) trial, aiming to enroll 508 patients. Trial 3 was a phase 2/3 trial, aiming to enroll 1409 patients.

Results: Trial 1 recruitment yielded a total of 24250 recorded endoscopies, trial 2 yielded a total of 15724, and trial 3 yielded 6772. Each recorded endoscopy was considered for study enrollment.

Discussion: By introducing a technology to capture and disseminate cases, many more patients were surfaced to study coordinators and approached for recruitment who may have otherwise been overlooked. This shows the potential for a video capture system to positively impact workflows, enabling more patients access to experimental therapies, in addition to expediting clinical trial recruitment time and efforts.


Disclosures:


Manisha Cole, , Safia Speer, , Brandon Davis, , Ian C. Strug, , Matt Schwartz, . P0680 - Endoscopy Recording in Inflammatory Bowel Disease Clinical Trial Recruitment, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.