基于风险的临床试验监测的挑战

M. Simović, N. Nikolić
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引用次数: 2

摘要

临床试验中监测活动的监督通常来自ICH GCP指南,涵盖了广泛的责任:试验进度监督,对研究方案的遵守,标准操作程序,良好临床实践,适用的监管要求以及源数据验证与病例报告表条目的准确性和完整性。基于风险的监测是由发起人、投资者和cro开发和采用的,以降低临床试验的成本,使研究管理更有效。EMA和FDA都在他们的论文中支持这种方法。有趣的是,EMA对“2012年GCP检查员工作组年度报告”的审查一致显示,在监测领域/领域中存在大量持续存在的发现,这些发现无法通过集中或有针对性的监测方法全部或部分捕获,也无法识别,例如基本文件、对sop的存在和遵守、培训和源文件的质量。这样的结果给发起人、cro和其他利益相关者带来了新的挑战。只要所有现行的ICH GCP指南都是临床研究的基石,监测计划和风险评估将包括监督除SDV之外的大量其他方面。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Challenges of risk-based monitoring of clinical trials
Abstract The oversight of monitoring activities in clinical trials generally comes from the ICH GCP Guidelines and covers a wide range of responsibilities: trial progress oversight, adherence to the Study Protocol, Standard Operating Procedures, Good Clinical Practice, applicable regulatory requirement(s) and Source Data verification vs accuracy and completeness of the Case Report Form entries. Risk-based monitoring was developed and adopted by Sponsors, Investors, and CROs to decrease the costs of clinical trials and make study management more effective. Both the EMA and the FDA support such an approach with their papers. Interestingly, the review of the EMA “Annual report of the GCP Inspectors working group in 2012” has consistently shown persistence of a significant number of findings in fields/areas of monitoring that cannot be fully or partially captured with a centralized or targeted monitoring approach and cannot be identified, such as essential documents, presence and adherence to SOPs, trainings, and the quality of source documentation. Such results open up new challenges for Sponsors, CROs, and other stakeholders. As long as all current ICH GCP Guidelines are a cornerstone of clinical research, monitoring plans and risk assessments will include overseeing a significant pool of additional aspects, apart from the SDV.
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