» Articles » PMID: 35959441

Real-world Evidence (RWE): A Challenge for Regulatory Agencies Discussion of the RWE Conference with the Network of the European Medicine Agencies, Patients, and Experts

Overview
Journal Front Pharmacol
Date 2022 Aug 12
PMID 35959441
Authors
Affiliations
Soon will be listed here.
Citing Articles

Patient and Public Involvement in Pharmacoepidemiological Research: An Environmental Scan of an Emerging Area.

Julie R, Yael B, Anais H, Anne T, Julie H, Marie V Pharmacoepidemiol Drug Saf. 2025; 34(1):e70080.

PMID: 39776060 PMC: 11706696. DOI: 10.1002/pds.70080.


Using real-world evidence data and digital monitoring to analyze the hepatotoxic profiles of biologics across more than two million patients.

Banerjee P, Preissner S, Preissner R Sci Rep. 2023; 13(1):10878.

PMID: 37407661 PMC: 10322819. DOI: 10.1038/s41598-023-37979-0.

References
1.
Eichler H, Pignatti F, Schwarzer-Daum B, Hidalgo-Simon A, Eichler I, Arlett P . Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. Clin Pharmacol Ther. 2020; 109(5):1212-1218. PMC: 8246742. DOI: 10.1002/cpt.2083. View

2.
Chodankar D . Introduction to real-world evidence studies. Perspect Clin Res. 2021; 12(3):171-174. PMC: 8323556. DOI: 10.4103/picr.picr_62_21. View

3.
Flynn R, Plueschke K, Quinten C, Strassmann V, Duijnhoven R, Gordillo-Maranon M . Marketing Authorization Applications Made to the European Medicines Agency in 2018-2019: What was the Contribution of Real-World Evidence?. Clin Pharmacol Ther. 2021; 111(1):90-97. PMC: 9299056. DOI: 10.1002/cpt.2461. View

4.
Eskola S, Leufkens H, Bate A, De Bruin M, Gardarsdottir H . Use of Real-World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018-2019. Clin Pharmacol Ther. 2021; 111(1):310-320. PMC: 9299055. DOI: 10.1002/cpt.2462. View

5.
Jabagi M, Botton J, Bertrand M, Weill A, Farrington P, Zureik M . Myocardial Infarction, Stroke, and Pulmonary Embolism After BNT162b2 mRNA COVID-19 Vaccine in People Aged 75 Years or Older. JAMA. 2021; 327(1):80-82. PMC: 8609457. DOI: 10.1001/jama.2021.21699. View