期刊
JOURNAL FOR IMMUNOTHERAPY OF CANCER
卷 8, 期 1, 页码 -出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/jitc-2019-000475
关键词
clinical trials as topic; immunotherapy; biomarkers; tumor; biostatistics; drug therapy; combination
资金
- EU ERAPerMed JTC2018-PEVOSQ-data project
The rapid rise to fame of immuno-oncology (IO) drugs has generated unprecedented interest in the industry, patients and doctors, and has had a major impact in the treatment of most cancers. An interesting aspect in the clinical development of many IO agents is the increasing reliance on nonconventional trial design, including the so-called 'master protocols' that incorporate various adaptive features and often heavily rely on biomarkers to select patient populations most likely to benefit. These novel designs promise to maximize the clinical benefit that can be reaped from clinical research, but are not without costs. Their acceptance as solid evidence basis for use outside of the research context requires profound cultural changes by multiple stakeholders, including regulatory bodies, decision-makers, statisticians, researchers, doctors and, most importantly, patients. Here we review characteristics of recent and ongoing trials testing IO drugs with unconventional design, and we highlight trends and critical aspects.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据