探索性临床试验相关概念及法规介绍

Concept and rules of exploratory clinical trial

探究性的临床试验为人们日益增多的药物研究活动提供了一种快捷的方法。此类临床研究通常是在早期临床发展的第一阶段进行,不以治疗为目的,也不侧重监测药物的临床耐受性,在研究过程中只涉及到少数人群并服用有限剂量。本文客观介绍了多种探究性临床试验方法及相关安全管理要求。在这基础之上,文章着重介绍并比较了探索性临床试验、微剂量试验及多剂量试验的概念。

Exploratory clinical trials provide a strategy for rapid human entry of investigational drugs. Such clinical studies are typically conducted during early clinical development in phase I as ifrst-in-human studies. They have no therapeutic intent and are not intended to examine clinical tolerability, which involve a small number of human subjects at limited dose. This review critically discusses the various exploratory clinical trial strategies, their advantages and disadvantages as well as the regulatory safety requirements. In this respect, strategies for exploratory investigational new drugs （eIND）, micro dose and multiple dose examination are highlighted and compared.