P675 CT-Scout platform, the digital solution to boost patient recruitment in inflammatory bowel disease clinical trials: A multicentre prospective observational comparative study
Y. Bouhnik1, X. Hebuterne2, M. Raith3, A. Amiot4, C. Tanasa Stefanescu1, D. Laharie5, X. Roblin6, A. Bourreille7, S. Nancey8, N. Sabbah9, L. Peyrin Biroulet10
1Hopital Beaujon, Service de Gastroentérologie,MICI et Assistance Nutritive, Clichy, France, 2Hopital Archet, Service de Gastroentérologie et Nutrition Clinique, Nice, France, 3CTMA, Project Manajer, Paris, France, 4Hopital Henri Mondor, Service de Gastroentérologie, Creteil, France, 5Hopital Haut-Léveque, Service d’Hépato-Gastroentérologie, Bordeaux, France, 6Hopital Bellevue, Service de Gastroentérologie, Saint Etienne, France, 7CHU Hotel-Dieu, Institut des maladies de l’appareil digestif, Nantes, France, 8Hopital Lyon Sud, Service d’hépatogastroentérologie, Lyon, France, 9CTMA, Chief Operating Officier, Paris, France, 10CHU Nancy, Hépato-Gastro-Entérologie, Nancy, France
Background
The main issue to validating new molecules in the field of IBD is insufficient patient enrollment into clinical trials, resulting in premature trials termination and cost increase. CT-SCOUT™ platform is a web-based solution to help clinicians to pre-screen potential candidates and facilitating the coordination of the research team. Our aim was to compare the number of patients enrolled in IBD clinical trials in sites equipped or not with CT-SCOUT™.
Methods
We conducted a prospective, multicenter, open-label, observational study in sites participating to phase 3 trials evaluating the efficacy and safety of etrolizumab in ulcerative colitis (UC, Hickory) and in Crohn’s disease (CD, Bergamot). Recruitment figures were provided by the sponsor, and we considered the 21 French sites equipped with CTscout and 134 sites in other countries not equipped with CT-SCOUT™. The primary endpoint was the mean number of patients randomised per site in both trials. Secondary endpoints included a mean number of patients randomised in each study. Patients screened and those finally randomised were compared in sites equipped and non-equipped using one-way ANOVA followed by post-hoc Tukey test and Mann–Whitney test.
Results
During the observational period of 40 months (September 2015–December 2018), 644 and 289 patients were screened and randomised in Hickory and/or Gardenia, respectively. There were 307 and 149 patients in 78 sites for Hickory, and 337 and 140 patients for Bergamot in 102 sites. The mean numbers of screened and randomised patients in CT-SCOUT™ equipped sites vs. non-equipped are given in the table.
| French sites equipped with CT-SCOUTTM | Sites from other countries non-equipped with CT-SCOUTTM | ||
| Screened in both studies (UC + CD) | 7.55 | 3.05 | |
| Randomised in both studies (UC + CD) | 3.79 | 1.28 | |
| Screened in Hickory (UC) | 9.17 | 3.14 | |
| Randomised in Hickory (UC) | 5.17 | 1.28 | |
| Screened in Bergamot (CD) | 5.94 | 2.95 | 0.003 |
| Randomised in Bergamot (CD) | 2.41 | 1.28 | 0.009 |
The mean number of patients randomised in Hickory in CT-SCOUT™ sites increased by 4.0 folds as compared with non-equipped sites (
Conclusion
This multicentric study demonstrated a significant increase in patient recruitment in IBD clinical trials. Randomisation rates were twice to four times higher in equipped sites compared with non-equipped ones. CT-SCOUT™ appears to be a promising digital solution to the global issue of patient enrollment in clinical trials.