长周期Ⅰ期临床试验受试者依从性管理

Compliance management of subjects in long period phase I clinical trial

临床试验周期长是影响受试者依从性的重要因素,提升受试者依从性、做好受试者管理是Ⅰ期临床试验质量保证的重要部分。本文对某三甲医院开展的长周期Ⅰ期临床试验受试者管理方式进行系统总结,深入分析长周期Ⅰ期临床试验特点,讨论受试者依从性管理的难点与问题,针对临床试验的关键环节提出有效解决方案,从多方面提高受试者依从性。

The long period of clinical trial is an important factor which affects the compliance of subjects. Improving the compliance of subjects and good subject management are important parts of quality management for phase Ⅰ clinical trials. In this article, we systematically summarize the management methods of subjects in long-period phase Ⅰ clinical trials carried out by a third-class hospital. After deep analysis on the characteristics of the long-period phase Ⅰ clinical trials, we discuss the difficulties and problems in subject compliance management, and propose effective solutions to improve subjects’ compliance from all aspects.