The utility of real‐world evidence for benefit‐risk assessment, communication, and evaluation of pharmaceuticals: Case studies-Reference-Cited by-同舟云学术

The utility of real‐world evidence for benefit‐risk assessment, communication, and evaluation of pharmaceuticals: Case studies

Published:2020-11-17 Issue:12 Volume:29 Page:1532-1539
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Radawski Christine A.¹^ORCID,Hammad Tarek A.²,Colilla Susan³,Coplan Paul⁴⁵,Hornbuckle Kenneth¹,Freeman Emily⁶,Smith Meredith Y.⁷⁸,Sobel Rachel E.⁹^ORCID,Bahri Priya¹⁰,Arias Ariel E.¹¹¹²,Bennett Dimitri⁵¹³^ORCID

Affiliation:

1. Eli Lilly and Company, Lilly Corporate Center Indianapolis Indiana USA

2. Sanofi Genzyme, Global Pharmacovigilance Cambridge Massachusetts USA

3. Teva Pharmaceuticals, RWE & Epidemiology, Global Health Economics and Outcomes Research West Chester Pennsylvania USA

4. Johnson & Johnson, Epidemiology New Brunswick New Jersey USA

5. Perelman School of Medicine, Adjunct, Center for Clinical Epidemiology and Biostatistics University of Pennsylvania Philadelphia Pennsylvania USA

6. Lundbeck Pharmaceuticals LLC, Global R&D Patient Insights, Deerfield Illinois USA

7. Amgen, Inc., Global Patient Safety & Pediatrics Thousand Oaks California USA

8. Department of Regulatory and Quality Sciences, School of Pharmacy University of Southern California Los Angeles California USA

9. United Biosource Corporation (UBC)/Senior Consulting Group Epidemiology, Blue Bell Pennsylvania USA

10. European Medicine Agency (EMA), Quality and Safety of Medicines Pharmacovigilance, Amsterdam Netherlands

11. Faculty of Pharmacy Université de Montréal Montreal Canada

12. Biologics and Genetic Therapies Directorate, Health Canada Ottawa Canada

13. Takeda Pharmaceutical Company Limited, Epidemiology Department Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5167

Reference38 articles.

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4. Health Canada.Optimizing the use of real world evidence to inform regulatory decision‐making; 2019.

5. 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)

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