新药临床试验方案设计的研究

Study on the design of clinical trial protocol for new drugs

目的研究新药临床试验设计方案。方法本文涉及临床试验设计中的研究目的、范围及对照药的剂量,以探讨试验设计的合理性。结果在众多的新药临床试验方案中发现,在研究目的、范围及对照药的剂量等方面存在很多问题,从而导致新药临床试验的失败,最终药品不能上市。为此本文通过案例为研究者及药品申办者提供了大量相关信息。结论试验设计是临床试验能否获得成功的关键之一。

Objective for new drugs. Methods To investigate the design of clinical trial protocol The study purpose, range and dose of control drugs were involved for discussion the appropriate trial design of these drugs. Results There were some problems of study purpose , selection dose of control drugs and study range . These new drugs have not appeared on the market induced by design failure. The article introduce the some examples in order to offer more information for the investigator and oppraiser. Conclusion Design is the key point of clinical trials.