P439 Patient’ recruitment for a Phase 3 inflammatory bowel disease (IBD) programme is significantly increased when accessing the CT-SCOUT™ platform
Y. Bouhnik1, X. Roblin2, R. Mrad3, X. Hebuterne4, D. Laharie5, C. Tanasa Stefanescu1, S. Nancey6, A. Boureille7, A. Amiot8, N. Sebbah9, L. Peyrin Biroulet10
1Hopital Beaujon, Service de Gastroentérologie- MICI et Assistance Nutritive, Clichy, France, 2Hôpital Bellevue, Service de Gastroentérologie, Saint Etienne, France, 3CTMA, Project Manager, Paris, France, 4Hôpital de l’Archet, Service de Gastroentérologie et Nutrition Clinique, Nice, France, 5Hôpital Haut Lévêque, Service d’Hépato-gastroentérologie, Bordeaux, France, 6Hôpital Lyon Sud, Service d’Hépatogastroentérologie, Lyon, France, 7CHU Hôtel Dieu, Institut des maladies de l’appareil digestif, Nantes, France, 8Hôpital Henri Mondor, Service d’Hépato-Gastro-Entérologie, Creteil, France, 9CTMA, Chief Operating Officer, Paris, France, 10CHU Nancy, Service d’Hépato-gastroentérologie, Nancy, France
Background
The main issue when validating new molecules in the field of IBD is insufficient patient recruitment into clinical trials, resulting in a considerable delay and cost increase. The selection of the best recruiting sites is a long and difficult process, especially since study sponsor has no visibility on the activity of the sites, and the sites have no penalties if the objectives are not achieved. The CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidate, facilitating the coordination of the research team and providing sponsor and principal investigator visibility into patient recruitment efforts and status on the site. We aimed to compare the recruitment rate in sites using the application according to Premium or Freemium modalities and in sites not equipped with CT-SCOUT™ for IBD clinical trials.
Methods
We conducted a prospective, multicentre, open-label, observational and comparative study in 25 sites participating in a selected phase 3 IBD clinical trials in France. All sites were proposed to be equipped with CT-SCOUT™, and the recruitment rate was compared according to 3 modalities: a) the Premium mode, giving access to all the functionalities of the application (including specific inclusion/exclusion criteria, possibility of sending notification to the team) in counterpart of which they undertook to use the application; b) the Freemium mode, a basic functionality that only gives the name of the study in the first selection phase; c) sites who were not interested to be equipped. The primary endpoint was the mean number of patients randomised per site per month. Patients screened and those finally randomised were compared in sites equipped (Premium or Freemium) and non-equipped using one-way ANOVA followed by post-hoc Tukey test.
Results
During the recruitment period from 4 to 36 months (mean 24.8 months), 221 and 130 patients were screened and randomised, respectively. The mean number of patients screened and randomised per site per month according to CT-SCOUT™ equipment is reported in the figure below.
Conclusion
This study shows that sites not equipped with CT-SCOUT™ recruit only a few patients. Among the equipped sites, those with Premium access have a significantly higher randomisation rate than those with limited functionality. Sites equipped with digital pre-screening support to facilitate patient recruitment and provide the sponsor visibility are the best candidates for trials.