抗肿瘤药物临床试验终点的技术指导原则

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1、抗肿瘤药物临床试验终点的技术指导原则2007年5月美国FDA发布2009年6月药审中心组织翻译百健艾迪艾尔斯制药有限公司翻译北核协会审核药审中心最终核准目录I.引言.............................................................................................................................1II.背景.............................................

2、...............................................................................1A.关于有效性的法规要求...............................................................................1B.抗癌药物审批终点的回顾.........................................................................

3、...2III.关于终点的一般性考虑...........................................................................................3A.总生存期...................................................................................................5B.基于肿瘤评价的终点...............................

4、....................................................51.无疾病生存期（Disease－FreeSurvival）......................................................62.客观缓解率(ObjectiveResponseRate)..............................................................73.肿瘤进展时间(TimetoProgression)

5、和无进展生存期(Progression-FreeSurvival)…………………………………………………………………….………....8a.TTP和PFS.......................................................................................................8b.PFS作为支持药物审批的终点.............................................................

6、..........8c.PFS试验设计问题...........................................................................................8d.PFS的分析.......................................................................................................94.至治疗失败时间（Time-to-TreatmentFailu

7、re）................................................9C.涉及症状评估的终点...................................................................................91.特定症状终点(SpecificSymptomEndpoint)......................................................102.症状数据(SymptomData)面临的

8、问题............................................................10D.生物标记物(Biomarkers)..........................................................................11IV.临床试验设计考虑........................