慢性丙型病毒性肝炎直接抗病毒药物临床试验设计和评价考虑要点

Consideration on design and evaluation of clinical trials of direct-acting antiviral drugs for chronic hepatitis C

随着慢性丙型病毒性肝炎直接抗病毒药物在国内外上市,国际上此类药物的临床试验设计和要求均发生了变化,本文在梳理此类药物临床试验设计演变的基础上,探讨了如何在与国际先进水平接轨的原则下,结合当前国内临床治疗实际,进行临床试验设计,以期为此类药物的研发提供一些参考。

With the approval of direct-acting antiviral drugs for chronic hepatitis C in domestic and abroad,the clinical trial design and requirements for such drugs have changed internationally.Based on the evolution of clinical trial design of such drugs,this paper discusses how to design the clinical trial under the principle of international advanced level,combined with the current domestic clinical practice,in order to provide some references for the development of such drugs.