Development of the clinical trial site performance metrics instrument: A study protocol

IF 1.6 Q2 MULTIDISCIPLINARY SCIENCES MethodsX Pub Date : 2025-01-08 DOI:10.1016/j.mex.2025.103165

Mattia Bozzetti , Rosario Caruso , Silvia Soncini , Monica Guberti

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Abstract

Clinical trials (CTs) are essential for medical advancements, yet their increasing complexity and cost demand improved efficiency in trial management. One major challenge in multicenter studies is the inconsistency in evaluating site performance. This study aims to develop and validate a Clinical Trial Site Performance Measure (CT-SPM) to assess “good performance” across trials. The tool will be tested and refined through psychometric analysis, resulting in both a comprehensive scale and a short form for universal application. The study is conducted in three phases: Phase 1 involves metric selection through expert consensus; Phase 2 focuses on psychometric testing to evaluate the reliability and validity of the instrument; and Phase 3 defines a cut-off for “good performance” using statistical models. This protocol aims to standardize site performance evaluation, potentially reducing research costs and enhancing trial quality.

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The study develops and validates a Clinical Trial Site Performance Measure (CT-SPM) using expert consensus and psychometric testing.
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A comprehensive and short-form tool will be created to evaluate site performance in multicenter clinical trials.
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A cut-off for “good performance” will be established using statistical models, facilitating consistent and efficient site evaluations.

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