医学
药物开发
抗癌药
药品
药品审批
重症监护医学
药理学
作者
Sharyl J. Nass,Mace L. Rothenberg,Rebecca D. Pentz,Hedvig Hricak,Amy P. Abernethy,Kenneth C. Anderson,Amanda Wagner Gee,R. Donald Harvey,Steven Piantadosi,Monica M. Bertagnolli,Deborah Schrag,Richard L. Schilsky
标识
DOI:10.1038/s41571-018-0102-3
摘要
The traditional approach to drug development in oncology, with discrete phases of clinical testing, is becoming untenable owing to expansion of the precision medicine paradigm, whereby patients are stratified into multiple subgroups according to the underlying cancer biology. Seamless approaches to drug development in oncology hold great promise of accelerating the accessibility of novel therapeutic agents to the public but are also accompanied by important trade-offs, including the limited availability of information on the clinical benefit and safety of novel agents at the time of market entry. In this Perspectives article, we describe several opportunities, in the form of novel trial designs or modelling strategies, to improve the efficiency of drug development in oncology, as well as new mechanisms to obtain information about anticancer therapies throughout their life cycle, such as innovative functional imaging techniques or the use of real-world clinical data.
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