新药临床试验的目的和设计

Objective and design methods of new drug clinical trials

药物在不同的临床研究阶段,研究目的、研究工作及研究方法各不相 同。本文针对不同阶段研究的目的和方法,阐述了临床试验的一般原则,以供 研究者在临床方案设计时参考。

The clinical studies in new drug research and development are generally conducted by phases. The study purposes, questions expected to be solved and methods are quite different at different clinical study phases. The article based on the clinical trial protocol design describes the considerations for investigator reference.