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 validation and reduction using advanced statistical approaches, including factor modeling, ROC curve analysis, and nonparametric scaling methods. The CT-SPM was assessed for structural validity, discriminative capacity, and feasibility for use in real-world settings. Results: From 126 potential indicators, 18 were retained and organized into four domains: Participant Retention and Consent, Data Completeness and Timeliness, Adverse Event Reporting, and Protocol Compliance. A bifactor model revealed two higher-order dimensions (participant-facing and data-facing performance), highlighting the multidimensional nature of site operations. A short form comprising four items demonstrated good scalability and sufficient…
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