抗菌药物临床试验技术指导原则的应用和分析.doc

摘 要 1988年我国卫生部组织起草颁布了《抗菌药物临床试验指导原则》，但此后的近20年，此指导原则未再进行过任何修订。随着各种抗菌药物临床试验的开展，抗菌药物相关的临床研究进展，GCP及相关法规的完善，此指导原则中原有的很多内容已经不再适合当前的临床试验现状。新版《抗菌药物临床试验技术指导原则》在2006年起草，于2008年完成了第三稿。相较旧版的技术指导原则，新版在很多方面进行了修订，增加了要求。 本文通过一个基本按照新版技术指导原则的要求进行的喹诺酮类抗菌药物的临床试验，从新版指导原则的主要修订思路出发，在方案设计、结果分析等方面对该指导原则进行验证，并与国外同类试验结果进行比对。另一方面，新的指导原则对临床试验带来新的管理问题，本文将结合实际工作，阐述在临床试验实施阶段，作为申办者在项目管理过程中的对风险管理的解决方案和分析。 本文通过一个完整的抗菌药物临床试验证明新的指导原则适用于目前的临床试验要求，但由于细菌感染性疾病复杂，进一步地指导国内抗菌药物的。Application and anaylsis for new guidline principles of antibacterial drugs clinical trails The China Ministry of Health published 《Guidance for clinical trials of anti-bacterial drugs》 in 1988。 Over the past 20 years, this version has never been modified. As the development of anti-bacterial clinical trials and GCP, the old version guidance became unsuitable for current situations. The new 《Guidance for clinical trials of anti-bacterial drugs》 had been drafting from 2006, and the 3rd draft was finished in 2008. Compare to the old version, new guidance changed a lot. Through a clinical test on Quinolones kind anti-bacterial drugs, basically practiced according to the requests of the new version of technique guidance principles, this article validated this guidance principles on the aspects of scheme design, result analyze and compared it to the similar test results overseas. On the other hand new guidance principles also brings new management issues on clinical test, this article will combine theory to practice, and expatiate the resolutions and analyses on the risk management in the process of project management This article proved the new guidance principles was suitable for the current requests of clinical tests, through a completed clinical anti-bacterial test. However, the kind of bacterial infection disease is very complex; we hope more sub technical guidance principles can become supplements to further effectively guide the clinical tests on domestic anti bacterial drugs. While as a applicant, we still need to intensivel