良好临床实践和临床试验质量认证:美国四个多中心试验方案依从性的回顾性分析

Jean-Marc C. Haeusler
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引用次数: 7

摘要

背景:良好临床规范(GCP)培训对临床研究专业人员的价值尚不清楚。本研究的目的是评估GCP正规培训对临床试验质量的影响。方法:回顾性分析2008年在美国进行的四项多中心试验收集的数据。作为医师调查员(CPI)或临床研究协调员(CCRC)的认证被用作GCP正式培训的证明。方案依从性被用作临床试验质量的代表,并通过方案偏差的数量来量化。分析的主要变量是每个随机受试者和地点的方案偏差数。结果:共有1418名受试者被随机分为101名调查员(29% CPI)和109名临床研究协调员(29% CCRC), 520个方案偏差。与“无认证”相比,方案偏差发生率的比值比(OR)为OR = 1.20(95%可信区间[0.852-1.688];p NS), OR = 0.70 ([0.513-0.953];“CPI-only”p = 0.0256),或= 0.37 ((0.273 - -0.507);p < 0.0001)为“CCRC + CPI”。结论:这项初步研究表明,GCP的正式培训有可能提高方案的依从性和临床试验质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Certification in good clinical practice and clinical trial quality: A retrospective analysis of protocol adherence in four multicenter trials in the USA
Background: The value of training in Good Clinical Practice (GCP) for clinical research professionals is unknown. The objective of this study was to assess the impact of formal training in GCP on the quality of clinical trials. Methods: Retrospective analysis of data collected from four multicenter trials conducted in the US in 2008. Certification as Physician Investigator (CPI) or Clinical Research Coordinator (CCRC) was used as proof of formal training in GCP. Protocol adherence was used as a proxy for the quality of clinical trials and quantified by the number of protocol deviations. The primary variable for analysis was the number of protocol deviations per randomized subject and site. Results: A total of 1,418 subjects were randomized by 101 investigators (29% CPI) and 109 clinical research coordinators (29% CCRC), with 520 protocol deviations. Compared to “no certification”, the Odds Ratios (OR) for the incidence of protocol deviations were OR = 1.20 (95% Confidence Interval [0.852–1.688]; p NS) for “CCRC-only”, OR = 0.70 ([0.513–0.953]; p = 0.0256) for “CPI-only”, and OR = 0.37 ([0.273–0.507]; p < 0.0001) for “CCRC + CPI”. Conclusions: This pilot study showed that formal training in GCP has the potential to improve protocol adherence and clinical trial quality.
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