CT-SCOUT App Markedly Improves Enrollment Rates for IBD Trials, Developer Says

CT-SCOUT App Markedly Improves Enrollment Rates for IBD Trials, Developer Says

Patient recruitment rates in recent international inflammatory bowel disease (IBD) clinical trials increased markedly when the CT-SCOUT digital solution was used, the technology’s developer announced.

The French start-up company Clinical Trials Mobile Application (CTMA) presented two scientific posters outlining results of its innovative platform during the recent annual meeting of the European Crohn’s and Colitis Organization (ECCO) in Vienna, Austria.

The multi-device technology is based on a unique algorithmic model that addresses patient attrition.

Currently used in 10 countries and 150 centers, the pre-screening web application enables physicians to detect in real time patients eligible for ongoing clinical trials, and quickly and easily facilitates research team coordination.

The overarching idea is that increased patient recruitment will reduce the duration of clinical trials, ultimately leading to more treatment options sooner and at less cost. The tool is touted as the missing link between study sponsors and clinical sites.

According to a CTMA press release, in a prospective, open-label, observational and comparative investigation involving 644 patients at 134 sites in six countries, sites that used CT-SCOUT experienced a 2.8-fold randomization rate increase over those that didn’t. The randomization rate in ulcerative colitis patients was four times higher, and 1.9-times more for those with Crohn’s disease. (In clinical trials, randomization is the process of assigning patients by chance to groups that receive different treatments.)

In a Phase 3 IBD study in France, sites using the tool randomized “significantly” more patients than those not equipped with the technology, the company said. Sites equipped with CT-SCOUT’s Premium mode, which includes all app functions, recorded 4.5-times more randomization than those not equipped, and 1.6-times more than those using the Freemium mode and its limited app functions.

“The main barrier to validating new molecules in the field of IBD is insufficient patient enrollment in clinical trials, resulting in premature termination of trials and increased costs,” said Laurent Peyrin-Biroulet, ECCO president. “CT-SCOUT is important for patients because it facilitates their enrollment in clinical trials. Before CT-SCOUT we missed out on a lot of patients. We now have dramatically increased enrollments into our studies.”

Based on a unique algorithm, CT-SCOUT is tailored to each center, improving the accuracy and time effectiveness of pre-screening activities. It includes each site’s academic and industry-sponsored studies, and reminds on-site healthcare professionals of recruitment activities and relevant elements. Clinicians have immediate access to patient data.

“In recent international prospective observational IBD trials, patient recruitment tripled in centers equipped with the CTMA solution, compared to unequipped centers,” said Norman Sabbah, CTMA chief operating officer. “CTMA stands out from the competition because its technology is based on a unique algorithm. It offers all the studies on one platform, along with a research team coordination system and a dashboard that gives sponsors visibility on the center’s activity in terms of patient recruitment.”

IBD affects some 5 million individuals worldwide.