Innovation in oncology clinical trial design

J. Verweij,H.R. Hendriks, H. Zwierzina, Hanauske, V. Wacheck,O. Collignon,P. Bruzzi,J. Gross, T. Riehl,F. Bretz, Dollins, I. Radtke

Cancer Treatment Reviews（2019）

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摘要

•Standard Phase III trials are not always suited to assess new targeted oncology drugs.•Innovative trial designs and alternative regulatory pathways are therefore needed.•Enabling patients earlier potential benefit from rapid access to these novel drugs.

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关键词

Oncology,Innovative clinical trial design,Drug development,Precision medicine,Estimand framework,Drug regulation

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