Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

被引：25

作者：

Khin, N. A. ^{[1
]}

Yang, P. ^{[2
]}

Hung, H. M. J. ^{[2
]}

Maung-U, K. ^{[1
]}

Chen, Y-F ^{[2
]}

Meeker-O'Connell, A. ^{[3
]}

Okwesili, P. ^{[3
]}

Yasuda, S. U. ^{[1
]}

Ball, L. K. ^{[4
]}

Huang, S-M ^{[5
]}

O'Neill, R. T. ^{[6
]}

Temple, R. ^{[1
,7
]}

机构：

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

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

[3] US FDA, Off Sci Invest, Off Compliance, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[4] US FDA, Off Int Programs, Off Global Regulatory Operat & Policy, Silver Spring, MD USA

[5] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[6] US FDA, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[7] US FDA, Off Ctr Director, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2013年 / 94卷 / 02期

关键词：

HEART-FAILURE; GEOGRAPHIC VARIABILITY; EXPLORATORY ANALYSES; INTERNATIONAL TRIAL; INTERVENTION TRIAL; CLINICAL-TRIALS; EFFICACY DATA; OUTCOMES; GLOBALIZATION; CLOPIDOGREL;

D O I：

10.1038/clpt.2013.70

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

引用

页码：230 / 242

页数：13

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