Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development
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ANALYTICAL REPORT
Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development Ruma Bhagat, MBBS, MPH1 · Lukasz Bojarski, PhD2 · Soazig Chevalier, MSc3 · Dagmar R. Görtz4 · Stéphanie Le Meignen, MS5 · Marcin Makowski, MD, PhD6 · Patrick Nadolny, MS7 · Marion Pillwein, PhD8 · Melissa Suprin, BChE, MBA9 · Sabine Turri, MS10 Received: 7 February 2020 / Accepted: 19 August 2020 © TransCelerate BioPharma Inc. 2020
Abstract 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. Keywords Quality tolerance limits · QTL · Quality management system · QMS · Key risk indicators · KRI
Introduction In the past decade, clinical development regulations have moved with the pharmaceutical industry to modernize clinical development and embrace the paradigms of * Ruma Bhagat [email protected] 1
Roche, 1 DNA Way, South San Francisco, CA 94404, USA
2
AstraZeneca, Postępu 14, 02‑676 Warsaw, Poland
3
Sanofi, 1 avenue Pierre Brossolette, 91385 Chilly Mazarin, France
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Janssen-Cilag GmbH, Johnson & Johnson Platz 1, 41470 Neuss, Germany
5
Bristol Myers Squibb, 3 rue Joseph Monier, 92506 Rueil‑Malmaison, France
risk-based quality management. A major revision to Good Clinical Practice (GCP) Guidelines occurred in November 2016 with the publication of the
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