Title:Barriers and Facilitators in Conducting Clinical Trials in Inflammatory Bowel Disease: A Monocentric Italian Survey
VOLUME: 15 ISSUE: 2
Author(s):Tiziana Larussa*, Evelina Suraci, Raffaella Marasco, Maria Imeneo, Dan L. Dumitrascu, Ludovico Abenavoli and Francesco Luzza
Affiliation:Department of Health Sciences, University of Catanzaro “Magna Graecia”, Catanzaro, Department of Health Sciences, University of Catanzaro “Magna Graecia”, Catanzaro, Department of Health Sciences, University of Catanzaro “Magna Graecia”, Catanzaro, Department of Health Sciences, University of Catanzaro “Magna Graecia”, Catanzaro, Second Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Department of Health Sciences, University of Catanzaro “Magna Graecia”, Catanzaro, Department of Health Sciences, University of Catanzaro “Magna Graecia”, Catanzaro
Keywords:Clinical trials, Crohn's Disease, health behaviors, inflammatory bowel diseases, patient-centered care, public
health, quality of life, ulcerative colitis.
Abstract:
Background: Clinical therapeutic trials are a fundamental tool for identifying and testing
new categories of drugs useful for ensuring clinical benefit in patients with Inflammatory Bowel
Diseases (IBD). A number of difficulties may affect the recruitment process in large clinical trials.
Objectives: In order to increase the involvement of patients within clinical trials in IBD therapy, it is
necessary to identify which factors could facilitate or discourage participation. The aim of this study
was to evaluate the factors influencing the participation in clinical trials in a consecutive series of patients
with IBD from a single referral center from Southern Italy.
Methods: Consecutive patients with Crohn´s Disease (CD) and Ulcerative Colitis (UC) were recruited
to complete a questionnaire dealing with their knowledge about clinical trials and attitudes towards
participation. Patients also completed the Short Inflammatory Bowel Disease Questionnaire
(S-IBDQ) to investigate their Quality of Life (QoL). Demographic and clinical data were recorded.
Results: Of the 145 consecutive patients invited to the survey, 132 completed the survey (91%
response rate). Of them, 67% claimed their willingness to take part in a clinical therapeutic trial for
IBD. Multivariate analysis showed a significant positive association between interest in clinical trials
and previous experience (p = 0.014), high education (p < 0.001), poor QoL (p = 0.016), money
retributions (p = 0.03) and informative materials (p = 0.02). On the other hand, a long-standing
disease (p = 0.017), the possibility of receiving a placebo (p = 0.04) and the frequent colonoscopies
required by the study protocol (p = 0.04) were significantly associated with the lack of interest in
clinical trials.
Conclusion: In a native local resident series of IBD patients, the majority of the patients were willing
to participate in a clinical therapeutic trial. A long-standing disease, placebo and invasive procedures
represented a barrier to enrollment while previous experience, high education, monetary compensation
and adequate information could be facilitative. Knowing barriers and facilitators affecting participation
in IBD clinical trials is of fundamental importance in order to increase the involvement of patients
in research and explore new treatment opportunities.
