Informing single-arm clinical trials with external controls

被引：25

作者：

Davi, Ruthie ^{[1
]}

Mahendraratnam, Nirosha ^{[2
]}

Chatterjee, Arnaub ^{[1
]}

Dawson, C. Jill ^{[3
]}

Sherman, Rachel ^{[4
]}

机构：

[1] Medidata Solut, New York, NY 10014 USA

[2] Duke Margolis Ctr Hlth Policy, Washington, DC USA

[3] Medidata Solut, Danville, CA USA

[4] Harvard Pilgrim Hlth Care Inst, Dept Populat Hlth, Boston, MA USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2020年 / 19卷 / 12期

关键词：

D O I：

10.1038/d41573-020-00146-5

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using historical clinical trial data and real-world data in external control arms for single-arm trials, as well as the associated challenges.

引用

页码：821 / 822

页数：2

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