我国药物Ⅰ期临床试验受试者招募及管理存在的问题

Problems in the recruitment and management of trial subjects for phase Ⅰ clinical trials in China

受试者招募是影响Ⅰ期临床试验质量的一个重要环节。本文针对我国Ⅰ期临床试验受试者招募与管理存在的问题,探讨相应的对策,以期保护受试者的权益和安全,提高我国药物I期临床试验的水平和质量。

Recruitment of trial subjects is an important part to affect the quality for phase I clinical trial. This paper reviews many problems in the recruitment and management of trial sub jects for phase I clinical trial at present, and ex- plores appropriate measures in order to protect the rights, benefits and safety of trial subjects,improve the level and quality o{ phase I clinical trials in China.