Quantitative Management Level Evaluation Model for Clinical Trials: A Multi-Indicator Approach
Authors: Zhang Wei, Li Na, Wang Fang, Chen Jie
Purpose: This study aims to develop a quantitative evaluation model for assessing the management level of clinical trials, addressing the need for a comprehensive and objective framework. Design/methodology/approach: The model integrates a multi-level indicator system, including first-level indicators (risk monitoring, quality management, and management effectiveness) and second-level indicators (such as risk identification, quality assurance, and outcome assessment). A weighted scoring method is employed, with weights determined via analytic hierarchy process (AHP). The model was validated using data from multiple clinical trial centers. Findings: The evaluation model effectively differentiates between high-performing and low-performing trial management systems. Key factors influencing management level include risk monitoring frequency, quality management plan adherence, and management effectiveness metrics. The model provides actionable insights for continuous improvement. Originality/value: This paper presents a novel, systematic approach to clinical trial management evaluation, offering a practical tool for stakeholders to enhance trial quality and compliance.
