Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: A systematic review

Sarah Goring; Aliki Taylor; Kerstin Müller; Tina Jun Jian Li; Ellen E. Korol; Adrian R. Levy; Nick Freemantle

doi:10.1136/bmjopen-2018-024895

Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: A systematic review

Sarah Goring, Aliki Taylor, Kerstin Müller, Tina Jun Jian Li, Ellen E. Korol, Adrian R. Levy, Nick Freemantle

Research output: Contribution to journal › Review article › peer-review

Original language	English
Article number	e024895
Journal	BMJ Open
Volume	9
Issue number	2
DOIs	https://doi.org/10.1136/bmjopen-2018-024895
Publication status	Published - Feb 1 2019
Externally published	Yes

ASJC Scopus Subject Areas

General Medicine

Keywords

external controls
non-randomised studies
regulatory submissions
systematic review

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1136/bmjopen-2018-024895

Cite this

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title = "Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: A systematic review",

keywords = "external controls, non-randomised studies, regulatory submissions, systematic review",

author = "Sarah Goring and Aliki Taylor and Kerstin M{\"u}ller and Li, {Tina Jun Jian} and Korol, {Ellen E.} and Levy, {Adrian R.} and Nick Freemantle",

note = "Publisher Copyright: {\textcopyright} 2019 Author(s).",

year = "2019",

month = feb,

day = "1",

doi = "10.1136/bmjopen-2018-024895",

language = "English",

volume = "9",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "2",

}

TY - JOUR

T1 - Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe

T2 - A systematic review

AU - Goring, Sarah

AU - Taylor, Aliki

AU - Müller, Kerstin

AU - Li, Tina Jun Jian

AU - Korol, Ellen E.

AU - Levy, Adrian R.

AU - Freemantle, Nick

PY - 2019/2/1

Y1 - 2019/2/1

KW - external controls

KW - non-randomised studies

KW - regulatory submissions

KW - systematic review

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UR - http://www.scopus.com/inward/citedby.url?scp=85062370399&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2018-024895

DO - 10.1136/bmjopen-2018-024895

M3 - Review article

C2 - 30819708

AN - SCOPUS:85062370399

SN - 2044-6055

VL - 9

JO - BMJ Open

JF - BMJ Open

IS - 2

M1 - e024895

ER -

Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: A systematic review

ASJC Scopus Subject Areas

Keywords

UN SDGs

Access to Document

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Cite this