Measuring What Matters in Trial Operations: Development and Validation of the Clinical Trial Site Performance Measure.

ABSTRACT: Background/Objectives: The execution of clinical trials is increasingly constrained by operational complexity, regulatory requirements, and variability in site performance. These challenges have direct implications for the reliability of trial outcomes. However, standardized methods to evaluate site-level performance remain underdeveloped. This study introduces the Clinical Trial Site Performance Measure (CT-SPM), a novel framework designed to systematically capture site-level operational quality and to provide a scalable short form for routine monitoring. Methods: We conducted a multicenter study across six Italian academic hospitals (January-June 2025). Candidate performance indicators were identified through a systematic review and expert consultation, followed by validati

SUBMITTER: Bozzetti M 

PROVIDER: S-EPMC12524836 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature