Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)

the ISPE Comparative Effectiveness Research Special Interest Group

doi:10.1002/cpt.1086

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)

the ISPE Comparative Effectiveness Research Special Interest Group

Research output: Contribution to journal › Comment/debate

34 Scopus citations

Abstract

On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)¹ by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.

Original language	English
Pages (from-to)	239-241
Number of pages	3
Journal	Clinical Pharmacology and Therapeutics
Volume	104
Issue number	2
DOIs	https://doi.org/10.1002/cpt.1086
State	Published - Aug 2018

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10.1002/cpt.1086

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@article{8bee4bc7f6b7484993a718a437d9270d,

title = "Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)",

abstract = "On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)1 by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.",

author = "\{the ISPE Comparative Effectiveness Research Special Interest Group\} and Hongbo Yuan and Ali, \{M. Sanni\} and Brouwer, \{Emily S.\} and Girman, \{Cynthia J.\} and Guo, \{Jeff J.\} and Lund, \{Jennifer L.\} and Elisabetta Patorno and Slaughter, \{Jonathan L.\} and Xuerong Wen and Dimitri Bennett",

note = "Publisher Copyright: {\textcopyright} 2018 American Society for Clinical Pharmacology and Therapeutics",

year = "2018",

month = aug,

doi = "10.1002/cpt.1086",

language = "English",

volume = "104",

pages = "239--241",

journal = "Clinical Pharmacology and Therapeutics",

issn = "0009-9236",

number = "2",

}

the ISPE Comparative Effectiveness Research Special Interest Group 2018, 'Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)', Clinical Pharmacology and Therapeutics, vol. 104, no. 2, pp. 239-241. https://doi.org/10.1002/cpt.1086

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG). / the ISPE Comparative Effectiveness Research Special Interest Group.
In: Clinical Pharmacology and Therapeutics, Vol. 104, No. 2, 08.2018, p. 239-241.

Research output: Contribution to journal › Comment/debate

TY - JOUR

T1 - Real-World Evidence

T2 - What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)

AU - the ISPE Comparative Effectiveness Research Special Interest Group

AU - Yuan, Hongbo

AU - Ali, M. Sanni

AU - Brouwer, Emily S.

AU - Girman, Cynthia J.

AU - Guo, Jeff J.

AU - Lund, Jennifer L.

AU - Patorno, Elisabetta

AU - Slaughter, Jonathan L.

AU - Wen, Xuerong

AU - Bennett, Dimitri

PY - 2018/8

Y1 - 2018/8

N2 - On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)1 by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.

AB - On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE)1 by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.

UR - https://www.scopus.com/pages/publications/85046443068

U2 - 10.1002/cpt.1086

DO - 10.1002/cpt.1086

M3 - Comment/debate

C2 - 29733448

AN - SCOPUS:85046443068

SN - 0009-9236

VL - 104

SP - 239

EP - 241

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 2

ER -

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG)

Abstract

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