基于需求层次理论的药物临床试验研究者管理机制的构建

The construction of management mechanism of drug clinical trial investigators based on hierarchy of needs theory

研究者作为临床试验的具体实施者,肩负保障临床试验质量的直接责任,其积极性及投入度是影响临床试验质量的因素之一。本文以马斯洛需求层次理论对临床试验研究者进行需求分析,进而制定涵括劳务分配体系、配套保障机制、良好沟通机制、科学考评体系、专业培训机制为一体的研究者管理机制,以期提升临床试验的质量与水平。

Investigators as clinical trials specific actors,are the key to quality assurance of clinical trials,and their enthusiasm and involvement are one of the factors affecting the quality of clinical research.Guided by Maslow's hierarchy of needs theory,this paper analyze the needs of clinical trial investigators,formulate a researcher management mechanism,which includes labor distribution system,supporting guarantee mechanism,good communication mechanism,scientific evaluation system,professional training system,in order to improve the quality and level of clinical trials.