Stakeholder analysis of clinical trials in China： a structural equation model

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.

本文通过利益相关者分析,确定了中国临床试验的利益相关者及其在临床试验中的影响;在访谈和文献研究的基础上,提出了利益相关者对临床试验影响机制的概念模型和研究假设;并用Amos17.0软件对模型进行检验。结果表明,政府和医疗机构对临床试验的影响最大,而申办者和公众对临床试验的影响没有统计学意义。为发展临床试验,申办者应该采取进一步措施促进临床试验的发展,公众也应该更多地参与到临床试验中。