A joint industry‐sponsored data monitoring committee model for observational, retrospective drug safety studies in the real‐world setting-Reference-Cited by-同舟云学术

A joint industry‐sponsored data monitoring committee model for observational, retrospective drug safety studies in the real‐world setting

Published:2020-11-24 Issue:1 Volume:30 Page:9-16
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Major‐Pedersen Atheline¹^ORCID,McCullen Mary Kate²,Sabol Mary Elizabeth³,Adetunji Omolara⁴,Massaro Joseph⁵,Neugut Alfred I.⁶,Sosa Julie Ann⁷,Hollenberg Anthony N.⁸

Affiliation:

1. Global Safety, Novo Nordisk A/S Copenhagen Denmark

2. US Patient Safety Surveillance, AstraZeneca Wilmington Delaware USA

3. Safety Evaluation & Risk Management, GlaxoSmithKline Philadelphia Pennsylvania USA

4. Global Patient Safety, Eli Lilly and Company Windlesham UK

5. Department of Biostatistics Boston University School of Public Health Boston Massachusetts USA

6. Departments of Medicine and Epidemiology Columbia University Medical Center New York New York USA

7. Department of Surgery University of California San Francisco (UCSF) San Francisco California USA

8. Joan and Sanford I. Weill Department of Medicine Weill Cornell Medicine, New York‐Presbyterian Hospital‐Weill Cornell Medical Center New York New York USA

Funder

AstraZeneca

Eli Lilly and Company

GlaxoSmithKline

Novo Nordisk

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5172

Reference33 articles.

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5. Heads of Medicines Agencies‐European Medicines Agency (HMA‐EMA).Joint Big Data Taskforce. Summary report EMA/105321/2019. 13 February 2019.https://www.actasanitaria.com/wp‐content/uploads/2019/02/ema‐joint‐task‐force‐big‐data‐summary‐report_en.pdf. Accessed 4 March 2019.

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