Barriers and Facilitators in Conducting Clinical Trials in Inflammatory Bowel Disease: A Monocentric Italian Survey

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.

Keywords: Clinical trials; Crohn's Disease; health behaviors; inflammatory bowel diseases; patient-centered care; public health; quality of life; ulcerative colitis..