Quality Management Model for Phase I Clinical Drug Trials: A Structural Equation Model

Area of Science:

• Clinical Pharmacology
• Health Services Research
• Drug Development

Background:

• Phase I clinical trials are critical for new drug development.
• Effective quality management is essential for the integrity and success of these early-phase trials.
• Existing quality management frameworks for phase I trials require refinement.

Purpose of the Study:

• To construct and validate a comprehensive quality management model for phase I clinical drug trials.
• To identify key factors influencing the quality of phase I clinical drug trials in China.
• To provide a framework for enhancing quality management practices in early-phase drug research.

Main Methods:

• A cross-sectional survey was administered to 604 respondents across 69 institutions in China.
• Exploratory and confirmatory factor analyses were employed to develop and validate the survey instrument.
• Structural equation modeling (SEM) was utilized to build and test the proposed quality management model.

Main Results:

• The developed survey tool demonstrated good reliability (Cronbach's α=0.938) and validity (RMSEA=0.074, CFI=0.962, TLI=0.955).
• The quality management model comprised five dimensions: government regulation, industry management, medical institution management, research team management, and contract research organization (CRO) management.
• SEM results indicated that government regulation, industry management, medical institution management, and CRO management significantly impacted trial quality (P<0.05), while research team management did not (P=0.610).

Conclusions:

• The validated quality management model offers a robust framework for assessing and improving phase I clinical trial quality.
• Government, industry, medical institutions, and CROs play significant roles in ensuring trial quality.
• The model provides actionable insights for optimizing quality management strategies in early-phase drug development.