Hurley Caroline, Sinnott Carol, Clarke Mike, Kearney Patricia, Racine Emmy, Eustace Joseph, Shiely Frances
Health Research Board-Trials Methodology Research Network (HRB-TMRN), National University of Ireland, Galway, Ireland.
Department of Public Health and Primary Care, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Trials. 2017 Sep 11;18(1):423. doi: 10.1186/s13063-017-2148-4.
In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM. The aim of this paper is to identify the attitudes and perceived barriers and facilitators to the implementation of RBM in academic-led clinical trials in Ireland.
This is a mixed-methods, explanatory sequential design, with quantitative survey followed by semistructured interviews. Academic clinical researchers (N = 132) working in Ireland were surveyed to examine their use and perceptions of RBM. A purposive sample of survey participants (n = 22) were then interviewed to gain greater insight into the quantitative findings. The survey and interview data were merged to generate a list of perceived barriers and facilitators to RBM implementation, with suggestions for, and solutions to, these issues.
Survey response rate was 49% (132/273). Thirteen percent (n = 18) of responders were not familiar with the term risk-based monitoring and less than a quarter of respondents (21%, n = 28) had performed RBM in a clinical trial. Barriers to RBM implementation included lack of RBM knowledge/training, increased costs caused by greater IT demands, increased workload for trial staff and lack of evidence to support RBM as an effective monitoring approach. Facilitators included participants' legal obligation to perform RBM under the new ICH-GCP guidelines, availability of RBM guidance and perception of cost savings by performing RBM in future trials.
The results of this study demonstrate a need for training and regulatory-endorsed guidelines to support the implementation of RBM in academic-led clinical trials. The study provides valuable insights to inform interventions and strategies by policy-makers and clinical trial regulators to improve RBM uptake.
2016年11月，国际人用药品注册技术协调会（ICH）发布要求，申办方需制定一种系统、有优先级、基于风险的临床试验监查方法。这种方法更广为人知的名称是基于风险的监查（RBM）。然而，近期证据表明不存在一种经过验证的RBM“金标准”方法，并且尚不清楚申办方将如何在其组织中引入RBM。了解RBM实施情况所需的第一步是探究学术试验者开展RBM的意愿和能力。本文旨在确定爱尔兰学术主导的临床试验中实施RBM的态度以及感知到的障碍和促进因素。
这是一项混合方法、解释性序列设计研究，先进行定量调查，随后进行半结构化访谈。对在爱尔兰工作的学术临床研究人员（N = 132）进行调查，以考察他们对RBM的使用情况和看法。然后对有目的抽取的部分调查参与者（n = 22）进行访谈，以更深入了解定量研究结果。将调查和访谈数据合并，生成一份RBM实施的感知障碍和促进因素清单，并针对这些问题提出建议和解决方案。
调查回复率为49%（132/273）。13%（n = 18）的回复者不熟悉基于风险的监查这一术语，不到四分之一的受访者（21%，n = 28）在临床试验中开展过RBM。RBM实施的障碍包括缺乏RBM知识/培训、因更高的信息技术需求导致成本增加、试验人员工作量增加以及缺乏证据支持RBM作为一种有效的监查方法。促进因素包括参与者根据新的ICH - GCP指南开展RBM的法律义务、RBM指南的可获取性以及认为在未来试验中开展RBM可节省成本。
本研究结果表明，需要培训和监管认可的指南来支持在学术主导的临床试验中实施RBM。该研究为政策制定者和临床试验监管机构提供了有价值的见解，以指导干预措施和策略，从而提高RBM的采用率。
