Ⅳ期临床试验规范化管理研究

Research on standardized management of the phase Ⅳ clinical trial

Ⅳ期临床试验在我国起步较晚,发展迅速,其研究意义和重要性也逐渐得到认可,但迅速发展的背后存在诸多应该防范的问题。明确Ⅳ期临床试验免费赠药问题、规范机构选择、扩大开展项目范围以及充分发挥机构及伦理委员会职能、强化Ⅳ期临床试验管理等方式,均可有效规范管理。

The phase IV clinical trial in China is making a rapid progress despite its late start and its research significance and importance have been recognized gradually. There exist many problems behind the rapid development, while these could be effectively managed and solved by the further definitude of free medicine in the phase IV clinical trial, selection of regulatory institutions, expansion of project scope,development of institutions and ethics committee functions and reinforcement of the IV clinical trial management.