Surrogate endpoints in clinical trials:when is good...good enough?  

作　　者：Jamie Olapo Schnuck Sardar Shahmir B.Chauhan Jonathan G.Sham 

机构地区：[1]Department of Surgery,University of Washington,Seattle,WA,USA [2]Fred Hutchinson Cancer Center,Seattle,WA,USA

出　　处：《Hepatobiliary Surgery and Nutrition》2024年第6期1062-1064,共3页肝胆外科与营养(英文)

摘　　要：The successful completion of practice-changing clinical trials is hampered by multiple potential challenges including regulatory procedures,patient recruitment,safety concerns,and cost(1).Study duration is a primary factor in clinical trial feasibility and several approaches have been employed to mitigate its impact.Overall survival(OS)has long been the predominant primary endpoint in cancer clinical trials due to its objectivity,clarity,patient benefit,and role in regulatory approval for new therapies.

关 键 词：Overall survival(OS) clinical trials recurrence-free survival(RFS) hepato-biliary-pancreatic malignancies surrogate endpoints 

分 类 号：R73[医药卫生—肿瘤]