Ther Innov Regul Sci. 2026 Jul 2. doi: 10.1007/s43441-026-01007-w. Online ahead of print.
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 | DOI:10.1007/s43441-026-01007-w
