Roche, 1 DNA Way, South San Francisco, CA, 94404, USA.
AstraZeneca, Postępu 14, 02-676, Warsaw, Poland.
Ther Innov Regul Sci. 2021 Mar;55(2):251-261. doi: 10.1007/s43441-020-00209-0. Epub 2020 Sep 3.
The International Council for Harmonisation (ICH) E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf . Accessed 5 Dec 2019) introduced Quality Tolerance Limits (QTLs) to the industry, and in doing so, modernized quality control for clinical trials. QTLs provide measured feedback on clinical trial parameters previously only used by statistical and clinical functions to track trial progress toward endpoints. Elevating these measures as part of the Quality Management System (QMS) provides greater visibility across clinical trial functions and the enterprise as well as to measures that are important indicators of the state of participant protection and reliability of trial results. In support of this new requirement, TransCelerate developed a framework to guide industry sponsors and their agents in implementing QTLs. This QTL Framework is intended to aid industry's ability to improve the quality of clinical research through the implementation of QTLs in a way that helps protect trial participants and reliability of trial results while meeting Health Authority (HA) expectations. The framework is intended to maximize efficiency and minimize confusion in the implementation of QTLs. The framework includes proposed approaches for implementation of QTLs for a clinical trial as defined in Section 5.0.4 and 5.0.7 of ICH E6(R2) (International Council for Harmonisation (ICH). ICH harmonised guideline: integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). 2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf . Accessed 5 Dec 2019) and considerations for setting thresholds.
国际协调理事会（ICH）E6(R2)（国际协调理事会（ICH）。ICH 协调指导原则：ICH E6(R1)综合增编：临床试验良好实践指导原则 E6(R2)。2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. 访问日期：2019 年 12 月 5 日）向业界引入了质量公差限制（QTL），从而使临床试验的质量控制现代化。QTL 为临床试验参数提供了可衡量的反馈，这些参数以前仅由统计和临床功能用于跟踪试验朝着终点的进展。将这些措施提升为质量管理体系（QMS）的一部分，为临床试验功能和整个企业提供了更大的可见性，以及对参与者保护和试验结果可靠性的重要指标的措施。为了支持这一新要求，TransCelerate 开发了一个框架，以指导行业赞助商及其代理商实施 QTL。该 QTL 框架旨在帮助行业提高临床研究质量，通过在帮助保护试验参与者和试验结果可靠性的同时满足卫生当局（HA）期望的方式实施 QTL。该框架旨在最大限度地提高实施 QTL 的效率并减少混乱。该框架包括根据 ICH E6(R2)第 5.0.4 和 5.0.7 节（国际协调理事会（ICH）。ICH 协调指导原则：ICH E6(R1)综合增编：临床试验良好实践指导原则 E6(R2)。2016. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf. 访问日期：2019 年 12 月 5 日）定义的临床试验实施 QTL 的拟议方法和设置阈值的考虑因素。
