Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms-Reference-Cited by-同舟云学术

Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms

Published:2020-03-11 Issue:10 Volume:29 Page:1228-1235
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Burcu Mehmet¹^ORCID,Dreyer Nancy A.²,Franklin Jessica M.³,Blum Michael D.⁴,Critchlow Cathy W.⁵,Perfetto Eleanor M.⁶,Zhou Wei¹

Affiliation:

1. Center for Observational and Real‐World Evidence Merck & Co., Inc. West Point Pennsylvania, United States

2. Real‐World Solutions IQVIA Cambridge Massachusetts

3. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital and Harvard Medical School Boston Massachusetts

4. Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology U.S. Food and Drug Administration White Oak Maryland

5. Center for Observational Research Amgen Inc. Thousand Oaks California

6. National Health Council Washington District of Columbia, and University of Maryland Baltimore (UMB), Baltimore, Maryland

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.4975

Reference45 articles.

1. Assessing the Gold Standard — Lessons from the History of RCTs

2. The Evolving Uses of “Real-World” Data

3. Transforming Evidence Generation to Support Health and Health Care Decisions

4. Real-World Evidence — What Is It and What Can It Tell Us?

5. U.S. Food and Drug Administration. Sentinel initiative.https://www.fda.gov/safety/fdassentinelinitiative/ucm2007250.htm. Accessed April 1 2019.

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