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

This study aimed to construct a quality management model for phase I clinical drug trials. A cross-sectional survey was conducted and data were collected from 604 respondents at 69 institutions in China engaged in phase I clinical drug trials. Exploratory and confirmatory factor analyses were used to develop the survey tool. Structural equation modeling was used to construct a quality management model for phase I clinical drug trials. The results showed that the final survey tool had good reliability and validity (Cronbach's α=0.938, root mean square error of approximation=0.074, comparative fit index=0.962, and Tucker-Lewis index=0.955). The model included five dimensions: government regulation, industry management, medical institution management, research team management, and contract research organization (CRO) management. In total, 22 measurement items were obtained. The structural equation model indicated government regulation, industry management, medical institution management, and CRO management significantly affected the quality of phase I clinical drug trials (β=0.195, β=0.331, β=0.279, and β=-0.267, respectively; P<0.05). Research team management had no effect on the quality of trials (β=0.041, P=0.610). In conclusion, the model is valuable for identifying factors influencing phase I clinical drug trials and guiding quality management practices.