临床试验现场性能度量工具的开发：研究方案。

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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引用次数: 0

摘要

临床试验（ct）对医学进步至关重要，但其日益增加的复杂性和成本要求提高试验管理的效率。多中心研究的一个主要挑战是评估站点性能的不一致性。本研究旨在开发和验证临床试验现场绩效评估（CT-SPM），以评估各试验的“良好表现”。该工具将通过心理测量分析进行测试和完善，从而产生一个全面的量表和一个通用的简短形式。研究分三个阶段进行：第一阶段通过专家共识选择度量标准；第二阶段的重点是心理测量测试，以评估仪器的信度和效度；阶段3使用统计模型定义“良好性能”的截止值。该协议旨在规范站点性能评估，潜在地降低研究成本并提高试验质量。•该研究开发并验证了临床试验现场性能测量（CT-SPM）使用专家共识和心理测量测试。•将创建一个综合和简短的工具来评估多中心临床试验中的现场表现。•将使用统计模型确定“良好表现”的截止日期，促进一致和有效的现场评价。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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

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

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.

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

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