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P051 Use of digital technology to boost patient recruitment in inflammatory bowel disease clinical trials

Bouhnik Y.*1, Amiot A.2, Alexandre N.1, Attar A.1, Kondamudi P.K.3, Stéfanescu C.1

1Beaujon Hospital, Gastroenterology, Clichy, France 2University Paris, Paris, France 3CTMA- Clinical Trials Mobile Application, Paris, France

Background

The weakest link in the long and expensive clinical trial process for the treatment of Inflammatory Bowel Disease (IBD) and other disabling chronic diseases is the patient recruitment. It has been estimated that insufficient patient enrollment in clinical trials can double the clinical development time and in certain cases cause premature termination of clinical trials [1]. As a leading academic research group, GETAID created CT-SCOUT™ platform, a software for clinicians to pre-screen candidates for trials which are actively recruiting in their center without requiring any prior knowledge of the ongoing trials.

Methods

A prospective, single center, open-labelled and observational pilot study was conducted with the objective to evaluate the benefits of implementing CT-SCOUT™ platform for patient enrollment into clinical trials within a tertiary-care center. All physicians in contact with IBD patients were asked to use the CT-SCOUT™ platform to evaluate whether patients were eligible for either academic or industry-sponsored trials. The primary endpoint was the patient randomization rate per month. The 21-month intervention period (Apr 2014 – Dec 2015) was compared with the previous 21-month reference period (Jul 2012 – Mar 2014) using Wilcoxon's matched-pair signed-rank test. Logistic regression analysis was performed to determine predictors of patient enrollment.

Results

After implementing CT-SCOUT™, the inclusion (i.e. defined as informed-consent form signature) and randomization rate increased from 1.7±1.4 to 4.7±3.1 (p=0.001), and from 1.2±1.2 to 3.5±2.8 (p=0.005) patients per month, respectively. During the 42-month study period, IBD patient population grew in terms of both consultations (from 219±48 to 270±57, p=0.002) and days hospitalizations (from 139±25 to 189±32, p=0.001), while the number of IBD hospitalizations, study coordinators and ongoing trials remained stable.

CT-SCOUT™ platform acted as predictor for higher patient randomization in clinical trials (OR =25.28; IC95% [5.26–1 032.77], p=0.002) as well as the monthly rate of IBD consultation >200/month (7.32; [0.95–386.45], p=0.05).

Conclusion

CT-SCOUT™ has multiplied the patient recruitment rate by a three-fold in clinical trials, regardless of increasing IBD patient cohort of the center. This application appears to be an easy-to-use solution to the global issue of patient enrollment in clinical trials.

References:

[1] Lamberti MJ, (2012), Evaluating the Impact Of Patient Recruitment And Retention Practices