When can real-world data generate real-world evidence?

被引：6

作者：

Rahman, Motiur ^{[1
]}

Dal Pan, Gerald ^{[2
]}

Stein, Peter ^{[3
]}

Levenson, Mark ^{[4
]}

Kraus, Stefanie ^{[5
]}

Chakravarty, Aloka ^{[6
]}

Rivera, Donna R. ^{[7
]}

Forshee, Richard ^{[8
]}

Concato, John ^{[1
,9
,10
]}

机构：

[1] US FDA, Off Med Policy, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[3] US FDA, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[4] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[5] US FDA, Off Regulatory Policy, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[6] US FDA, Off Commissioner, Silver Spring, MD USA

[7] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA

[8] US FDA, Off Biostat & Pharmacovigilance, Ctr Biol Evaluat & Res, Silver Spring, MD USA

[9] Yale Univ, Sch Med, Dept Med, New Haven, CT USA

[10] 10903 New Hampshire Ave, Silver Spring, MD 20993 USA

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2024年 / 33卷 / 01期

关键词：

biologics; cures act; drugs; real-world data; real-world evidence; study design;

D O I：

10.1002/pds.5715

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

引用

页数：4

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