关键词: 临床试验, 利益相关者, 结构方程模型

Abstract:

Stakeholder analysis was conducted to define stakeholders and their role in clinical trials; a conceptual model and hypotheses regarding the relationship of each stakeholder were then constructed based on pharmaceutical regulations in China and interviews with experts; Amos 17.0 was utilized to test the model and path analysis. We found that government and hospital are the most powerful stakeholders, while the public and sponsor have little impact on clinical trials. Further measures should be taken by sponsors to promote the development of clinical trials, and the public should be more involved in clinical research.

Key words: Clinical trial, Stakeholder analysis, Structural equation model