Department of Health Sciences, University of Catanzaro "Magna Graecia", Catanzaro, Italy.
Second Medical Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Rev Recent Clin Trials. 2020;15(2):137-144. doi: 10.2174/1574887115666200224113520.
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.
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.
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.
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.
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.
临床治疗试验是确定和测试新类别的药物的基本工具，这些药物有助于为炎症性肠病（IBD）患者带来临床获益。许多困难可能会影响大型临床试验的招募过程。
为了增加 IBD 治疗临床试验中患者的参与度，有必要确定哪些因素可能促进或阻碍参与。本研究旨在评估影响来自意大利南部单一转诊中心的连续 IBD 患者参与临床试验的因素。
连续招募克罗恩病（CD）和溃疡性结肠炎（UC）患者完成一份调查问卷，涉及他们对临床试验的了解和对参与的态度。患者还填写了简短的炎症性肠病问卷（S-IBDQ）以评估他们的生活质量（QoL）。记录了人口统计学和临床数据。
在受邀参加调查的 145 名连续患者中，有 132 名完成了调查（响应率为 91%）。其中，67%的人表示愿意参加 IBD 的临床治疗试验。多变量分析显示，对临床试验的兴趣与先前的经验（p=0.014）、高教育程度（p<0.001）、较差的 QoL（p=0.016）、经济回报（p=0.03）和信息材料（p=0.02）之间存在显著正相关。另一方面，疾病的长期存在（p=0.017）、接受安慰剂的可能性（p=0.04）和研究方案所需的频繁结肠镜检查（p=0.04）与对临床试验缺乏兴趣显著相关。
在一项本地居民 IBD 患者的系列研究中，大多数患者愿意参加临床治疗试验。长期疾病、安慰剂和侵入性程序是参与的障碍，而先前的经验、高教育程度、经济补偿和充分的信息可能是促进因素。了解影响 IBD 临床试验参与的障碍和促进因素对于增加患者对研究的参与度和探索新的治疗机会至关重要。
