Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY
J C Poythress, Jin Hyung Lee, Kentaro Takeda, Jun Liu
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引用次数: 0

Abstract

In alignment with the ICH guideline for Good Clinical Practice [ICH E6(R2)], quality tolerance limit (QTL) monitoring has become a standard component of risk-based monitoring of clinical trials by sponsor companies. Parameters that are candidates for QTL monitoring are critical to participant safety and quality of trial results. Breaching the QTL of a given parameter could indicate systematic issues with the trial that could impact participant safety or compromise the reliability of trial results. Methods for QTL monitoring should detect potential QTL breaches as early as possible while limiting the rate of false alarms. Early detection allows for the implementation of remedial actions that can prevent a QTL breach at the end of the trial. We demonstrate that statistically based methods that account for the expected value and variability of the data generating process outperform simple methods based on fixed thresholds with respect to important operating characteristics. We also propose a Bayesian method for QTL monitoring and an extension that allows for the incorporation of partial information, demonstrating its potential to outperform frequentist methods originating from the statistical process control literature.

质量容限 (QTL) 监测的贝叶斯方法。
根据《国际化学品管理委员会良好临床实践指南》[ICH E6(R2)],质量耐受限度(QTL)监测已成为申办公司对临床试验进行风险监测的标准组成部分。作为 QTL 监测对象的参数对参与者的安全和试验结果的质量至关重要。突破特定参数的 QTL 可能表明试验存在系统性问题,从而影响受试者的安全或损害试验结果的可靠性。QTL 监测方法应尽早发现潜在的 QTL 缺陷,同时限制误报率。及早检测可以采取补救措施,防止试验结束时出现 QTL 缺陷。我们证明,考虑到数据生成过程的预期值和变异性的统计方法在重要操作特征方面优于基于固定阈值的简单方法。我们还提出了一种用于 QTL 监测的贝叶斯方法,以及一种允许纳入部分信息的扩展方法,证明了其优于源于统计过程控制文献的频数主义方法的潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pharmaceutical Statistics
Pharmaceutical Statistics 医学-统计学与概率论
CiteScore
2.70
自引率
6.70%
发文量
90
审稿时长
6-12 weeks
期刊介绍: Pharmaceutical Statistics is an industry-led initiative, tackling real problems in statistical applications. The Journal publishes papers that share experiences in the practical application of statistics within the pharmaceutical industry. It covers all aspects of pharmaceutical statistical applications from discovery, through pre-clinical development, clinical development, post-marketing surveillance, consumer health, production, epidemiology, and health economics. The Journal is both international and multidisciplinary. It includes high quality practical papers, case studies and review papers.
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