Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases.

导出 OA

翻译打印收藏纠错

作者： Thomas,Staab ^[1] ; Georg,Isbary ^[1] ; Volker E,Amelung ^[2] ; Jörg,Ruof ^[3]

作者单位： Roche Pharma AG, Emil-Barrell-Str. 1, 79639, Grenzach-Wyhlen, Germany. ^[1] Medical School of Hanover, Hanover, Germany. ^[2] Roche Pharma AG, Emil-Barrell-Str. 1, 79639, Grenzach-Wyhlen, Germany. joerg.ruof@bluewin.ch. ^[3] Medical School of Hanover, Hanover, Germany. joerg.ruof@bluewin.ch. ^[4]

关键词 AMNOG Early benefit assessment HTA Marketing authorisation Morbidity Primary endpoint

主题词药物批准(Drug Approval);德国(Germany);人类(Humans);代谢疾病(Metabolic Diseases);年患病率(Morbidity);肿瘤(Neoplasms);技术评估, 生物医学(Technology Assessment, Biomedical)

DOI 10.1186/s12913-016-1902-8

PMID 27842592

发布时间 2024-03-26

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交