{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,7]],"date-time":"2025-06-07T17:22:36Z","timestamp":1749316956215,"version":"3.40.5"},"reference-count":41,"publisher":"Bentham Science Publishers Ltd.","issue":"2","content-domain":{"domain":["eurekaselect.com"],"crossmark-restriction":true},"short-container-title":["RRCT"],"published-print":{"date-parts":[[2020,6,17]]},"abstract":"<jats:sec>\n<jats:title>Background:<\/jats:title>\n<jats:p>Clinical therapeutic trials are a fundamental tool for identifying and testing\nnew categories of drugs useful for ensuring clinical benefit in patients with Inflammatory Bowel\nDiseases (IBD). A number of difficulties may affect the recruitment process in large clinical trials.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Objectives:<\/jats:title>\n<jats:p> In order to increase the involvement of patients within clinical trials in IBD therapy, it is\nnecessary to identify which factors could facilitate or discourage participation. The aim of this study\nwas to evaluate the factors influencing the participation in clinical trials in a consecutive series of patients\nwith IBD from a single referral center from Southern Italy.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods:<\/jats:title>\n<jats:p> Consecutive patients with Crohn\u00b4s Disease (CD) and Ulcerative Colitis (UC) were recruited\nto complete a questionnaire dealing with their knowledge about clinical trials and attitudes towards\nparticipation. Patients also completed the Short Inflammatory Bowel Disease Questionnaire\n(S-IBDQ) to investigate their Quality of Life (QoL). Demographic and clinical data were recorded.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results:<\/jats:title>\n<jats:p>Of the 145 consecutive patients invited to the survey, 132 completed the survey (91%\nresponse rate). Of them, 67% claimed their willingness to take part in a clinical therapeutic trial for\nIBD. Multivariate analysis showed a significant positive association between interest in clinical trials\nand previous experience (p = 0.014), high education (p &lt; 0.001), poor QoL (p = 0.016), money\nretributions (p = 0.03) and informative materials (p = 0.02). On the other hand, a long-standing\ndisease (p = 0.017), the possibility of receiving a placebo (p = 0.04) and the frequent colonoscopies\nrequired by the study protocol (p = 0.04) were significantly associated with the lack of interest in\nclinical trials.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Conclusion:<\/jats:title>\n<jats:p>In a native local resident series of IBD patients, the majority of the patients were willing\nto participate in a clinical therapeutic trial. A long-standing disease, placebo and invasive procedures\nrepresented a barrier to enrollment while previous experience, high education, monetary compensation\nand adequate information could be facilitative. Knowing barriers and facilitators affecting participation\nin IBD clinical trials is of fundamental importance in order to increase the involvement of patients\nin research and explore new treatment opportunities.<\/jats:p>\n<\/jats:sec>","DOI":"10.2174\/1574887115666200224113520","type":"journal-article","created":{"date-parts":[[2020,2,24]],"date-time":"2020-02-24T14:21:24Z","timestamp":1582554084000},"page":"137-144","update-policy":"https:\/\/doi.org\/10.2174\/bsp_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Barriers and Facilitators in Conducting Clinical Trials in Inflammatory Bowel Disease: A Monocentric Italian Survey"],"prefix":"10.2174","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6998-8502","authenticated-orcid":true,"given":"Tiziana","family":"Larussa","sequence":"first","affiliation":[{"name":"Department of Health Sciences, University of Catanzaro \u201cMagna Graecia\u201d, Catanzaro, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7880-762X","authenticated-orcid":true,"given":"Evelina","family":"Suraci","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Catanzaro \u201cMagna Graecia\u201d, Catanzaro, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6918-8169","authenticated-orcid":true,"given":"Raffaella","family":"Marasco","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Catanzaro \u201cMagna Graecia\u201d, Catanzaro, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7544-3592","authenticated-orcid":true,"given":"Maria","family":"Imeneo","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Catanzaro \u201cMagna Graecia\u201d, Catanzaro, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5404-7662","authenticated-orcid":true,"given":"Dan L.","family":"Dumitrascu","sequence":"additional","affiliation":[{"name":"Second Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5922-1524","authenticated-orcid":true,"given":"Ludovico","family":"Abenavoli","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Catanzaro \u201cMagna Graecia\u201d, Catanzaro, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5120-1046","authenticated-orcid":true,"given":"Francesco","family":"Luzza","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, University of Catanzaro \u201cMagna Graecia\u201d, Catanzaro, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"965","reference":[{"key":"ref=1","doi-asserted-by":"publisher","first-page":"349","DOI":"10.1053\/j.sempedsurg.2017.10.003","volume":"26","author":"Yu Y.R.","year":"2017","unstructured":"Yu Y.R.; Rodriguez J.R.; Clinical presentation of Crohn\u2019s, ulcerative colitis, and indeterminate colitis: Symptoms, extraintestinal manifestations, and disease phenotypes. 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