Understanding the Added Value of Action Limits for QTL Monitoring.

Authors

Nathalie van Borrendam, Annett Keller, Leon Els, Sowmya Gabbula, Steven Gilbert, Debra Jendrasek, Marcus E Muli, Stefano Saino, Laura Trotta, Anandavalli Thiagarajan

Published in

Therapeutic innovation & regulatory science. Jul 02, 2026. Epub Jul 02, 2026.

Abstract

QTLs aim to ensure that the impact of risks on critical quality aspects of the trial remains within an acceptable range. Action limits can serve as an effective mechanism for the early detection of potential risks, emphasizing the importance of continuous, real-time data monitoring throughout the course of a clinical trial. A breach of an action limit constitutes an early warning of a potential negative impact on trial quality, which could subsequently affect statistical analyses. This paper presents practical examples to elucidate common characteristics of QTL parameters, thresholds, and their associated action limits.

PMID:
42390815
Bibliographic data and abstract were imported from PubMed on 02 Jul 2026.

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